Photodynamic Bone Stabilization Procedure Pack
Catalog Number: | USML-1310070 |
---|---|
Company Name: | ILLUMINOSS MEDICAL, INC. |
Device Combination Product: | N/A |
Device Commercial Dsitribution End Date: | 2020-08-28 |
Device Commercial Dsitribution Status: | Not in Commercial Distribution |
Device Count: | 1 |
Device Description: | Photodynamic Bone Stabilization Procedure Pack |
Device hctp: | N/A |
Device kit: | N/A |
Device Publish Date: | 2019-07-23 |
Device Record Status: | Published |
Direct Market Exempt: | N/A |
Has Donation ID number? | true |
DUNS Number: | 859664661 |
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: | MR Conditional |
Is OTC? | N/A |
Is Devic Premarket Exempt: | N/A |
Public Device Record Key: | 7ef1875d-ab13-4218-b9e5-2c9f0ca9110f |
Public Version Date: | 2020-08-31 |
Public Version Number: | 2 |
Public Version Status: | Update |
Is Rx? | true |
Has Serial Number? | N/A |
Is Single Use: | true |
Version Model Number: | USML-1310070 |
Adress: | N/A |
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
Orthopaedic bone pin, non-bioabsorbable
A small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
USML1310070
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
true
false
Product Codes
Product Code
Product Code Name
QAD
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Pre Market Submisison
Submission Number
Supplement Number
DEN160062
000