infinity OCTAGON
| Catalog Number: | 504108 |
|---|---|
| Company Name: | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | 2018-04-25 |
| Device Commercial Dsitribution Status: | Not in Commercial Distribution |
| Device Count: | 1 |
| Device Description: | Tissue Level Implant Regular Platform Ø4,1x8 |
| Device hctp: | N/A |
| Device kit: | N/A |
| Device Publish Date: | 2015-08-30 |
| Device Record Status: | Published |
| Direct Market Exempt: | N/A |
| Has Donation ID number? | N/A |
| DUNS Number: | 318034329 |
| Has Expiration Date? | true |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | N/A |
| Has Lot Batch Number: | true |
| Has Manufacutring Date: | N/A |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | N/A |
| Is Devic Premarket Exempt: | N/A |
| Public Device Record Key: | 5430204d-af87-4e34-8ebf-c80ffcf92107 |
| Public Version Date: | 2018-04-26 |
| Public Version Number: | 3 |
| Public Version Status: | Update |
| Is Rx? | true |
| Has Serial Number? | N/A |
| Is Single Use: | true |
| Version Model Number: | 504108 |
| Adress: | Phone:+1(508)588-3100 Extension: Email: kathystrange@acesurgical.com |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
Screw endosteal dental implant, two-piece
A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
XXXX5041089
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
true
false
Product Codes
Product Code
Product Code Name
DZE
Implant, Endosseous, Root-Form
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A