Fine Osteotomy Implant and Disposable Instrumentation Tray
- Primary DI
- 00688346000085
- Brand
- Fine Osteotomy Implant and Disposable Instrumentation Tray
- Company
- Laboratoires Bodycad Inc
- Model
- 025-004
- Catalog number
- 025-004
- Published
- 2020-05-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FSM | Tray, Surgical, Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00688346000085 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00688346000085 | 00688346000085 | 688346000085 | 0688346000085 |
GMDN Terms
| Term | Definition |
|---|
| Instrument tray | A container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 202981171
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00688346000047 | Fine Osteotomy system - Proximal tibia | 015-410-001 | 015-410-001 | 2020-05-20 |
| 00688346000078 | Fine Osteotomy system - Distal femur | 015-330-001 | 015-330-001 | 2020-05-20 |
| 00688346000108 | Fine Osteotomy implants - Distal femur | 015-330-101 | 015-330-101 | 2020-05-20 |
| 00688346000122 | Fine Osteotomy implants - Proximal tibia | 015-410-101 | 015-410-101 | 2020-05-20 |
| 00688346000283 | Fine Osteotomy system - Distal femur | 015-330-002 | 015-330-002 | 2020-05-20 |
| 00688346000290 | Fine Osteotomy system - Distal femur | 015-330-003 | 015-330-003 | 2020-05-20 |
| 00688346000320 | Fine Osteotomy system - Distal femur | 015-330-006 | 015-330-006 | 2020-05-20 |
| 00688346000337 | Fine Osteotomy system - Distal femur | 015-330-007 | 015-330-007 | 2020-05-20 |
| 00688346000344 | Fine Osteotomy implants - Distal femur | 015-330-102 | 015-330-102 | 2020-05-20 |
| 00688346000351 | Fine Osteotomy implants - Distal femur | 015-330-103 | 015-330-103 | 2020-05-20 |
| 00688346000368 | Fine Osteotomy implants - Distal femur | 015-330-104 | 015-330-104 | 2020-05-20 |
| 00688346000375 | Fine Osteotomy implants - Distal femur | 015-330-105 | 015-330-105 | 2020-05-20 |
| 00688346000382 | Fine Osteotomy implants - Distal femur | 015-330-106 | 015-330-106 | 2020-05-20 |
| 00688346000399 | Fine Osteotomy implants - Distal femur | 015-330-107 | 015-330-107 | 2020-05-20 |
| 00688346000405 | Fine Osteotomy system - Proximal tibia | 015-410-002 | 015-410-002 | 2020-05-20 |
| 00688346000412 | Fine Osteotomy system - Proximal tibia | 015-410-003 | 015-410-003 | 2020-05-20 |
| 00688346000429 | Fine Osteotomy system - Proximal tibia | 015-410-004 | 015-410-004 | 2020-05-20 |
| 00688346000436 | Fine Osteotomy system - Proximal tibia | 015-410-005 | 015-410-005 | 2020-05-20 |
| 00688346000443 | Fine Osteotomy system - Proximal tibia | 015-410-006 | 015-410-006 | 2020-05-20 |
| 00688346000450 | Fine Osteotomy system - Proximal tibia | 015-410-007 | 015-410-007 | 2020-05-20 |
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