FDA UDI
In Commercial Distribution
🇺🇸 United States
ACF
DI: 10705034810072
·
Model: SD396.401
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ACF
- Primary DI
- 10705034810072
- Version / Model
- SD396.401
- Catalog Number
- SD396401
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 3
- Public Version Date
- 2022-04-27
- Public Version Status
- Update
- Public Device Record Key
- fb70778b-7441-426e-aa51-88c07b4db94c
Device Description
ACF ALLOGRAFT INSERTER WITH STOPS
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44869 | Orthopaedic graft inserter | A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H981SD3964010 | HIBCC | ||||
| Primary | 10705034810072 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]