FDA UDI
In Commercial Distribution
🇺🇸 United States
Contour
DI: 03596010293329
·
Model: 71337162
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Contour
- Primary DI
- 03596010293329
- Version / Model
- 71337162
- Catalog Number
- 71337162
- 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
- 7
- Public Version Date
- 2024-10-11
- Public Version Status
- Update
- Public Device Record Key
- 0116c021-1821-43d4-9a66-16d244e93a32
Device Description
CONTOUR ACETABULAR RECONSTRUCTION RING 62MM OUTER DIAMETER 58MM INNER DIAMETER LEFT
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JDJ | Mesh, surgical, acetabular, hip, prosthesis | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60516 | Metallic acetabulum prosthesis | A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010293329 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- : -