FDA UDI
In Commercial Distribution
🇺🇸 United States
GRAFTMASTER
DI: 03596010025784
·
Model: 014412
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GRAFTMASTER
- Primary DI
- 03596010025784
- Version / Model
- 014412
- Catalog Number
- 014412
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-30
- Public Version
- 6
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 3c35bbb5-720a-4955-8d2c-06582dc0af43
Device Description
REPLACEMENT GRAFTMASTER II TISSUE GRASPER
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 |
|---|---|---|---|---|
| HWT | TEMPLATE | Orthopedic | 888.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56650 | Tendon/ligament graft preparation station base | A component of a graft preparation station designed to provide a stable platform for the operator when preparing and pretensioning a ligament and/or tendon graft prior to implantation. It is available in a variety of sizes and typically consists of a flat base onto which the graft is positioned, clamped and tensioned with selected posts, clamps and tensioning devices that are fixed to this device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010025784 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]