FDA UDI
In Commercial Distribution
🇺🇸 United States
REDAPT
DI: 00885556320143
·
Model: 71354425
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REDAPT
- Primary DI
- 00885556320143
- Version / Model
- 71354425
- Catalog Number
- 71354425
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-23
- Public Version
- 5
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 0b6ec628-1936-4c3c-8626-ccb54064ec0d
Device Description
REDAPT Slice Augment 74 MM x 24MM
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61780 | Acetabular augmentation implant | A sterile implantable device intended to help prevent dislocation of a total hip replacement by augmenting the posterior lip of the acetabulum around a retained acetabular prosthesis, or to help fill bone defects not covered by the acetabular prosthesis. It is designed to help constrain the femoral head and/or provide additional support for the acetabular prosthesis. It is available in various shapes, is typically made of metal [e.g. Titanium alloy] and/or polymer, and may be fixed with screws and/or cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885556320143 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]