FDA UDI
In Commercial Distribution
🇺🇸 United States
G7® Revision Acetabular System
DI: 00889024686496
·
Model: 757400042
·
Zimmer, Inc.
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- G7® Revision Acetabular System
- Primary DI
- 00889024686496
- Version / Model
- 757400042
- Catalog Number
- 757400042
- Company Name
- Zimmer, Inc.
- Labeler DUNS
- 056038268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-10
- Public Version
- 1
- Public Version Date
- 2026-02-18
- Public Version Status
- New
- Public Device Record Key
- d259996d-a0ae-4710-96d8-31d2c88d4652
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
- 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
- No
- 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 |
| OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented | Orthopedic | 888.3353 | 2 |
| OQH | Hip, semi-constrained, cemented, metal/polymer + additive, cemented | Orthopedic | 888.3350 | 2 |
| OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented | Orthopedic | 888.3358 | 2 |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer | Orthopedic | 888.3310 | 2 |
| PBI | prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive | Orthopedic | 888.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43167 | Acetabular shell | An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024686496 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252623 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 42 | Millimeter |