FDA UDI
In Commercial Distribution
🇺🇸 United States
BC Reflex Uni Reusable Surgical Instrument Set
DI: 00688346002478
·
Model: 027-003
·
Laboratoires Bodycad Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BC Reflex Uni Reusable Surgical Instrument Set
- Primary DI
- 00688346002478
- Version / Model
- 027-003
- Catalog Number
- 027-003
- Company Name
- Laboratoires Bodycad Inc
- Labeler DUNS
- 202981171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-13
- Public Version
- 1
- Public Version Date
- 2021-12-22
- Public Version Status
- New
- Public Device Record Key
- 2e8cd6c0-d57e-4f71-b391-a614ee7eb771
Device Description
Reusable Surgical Instrument Set
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34195 | Unicondylar knee prosthesis | A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00688346002478 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211646 | 000 |