FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00889024458963
·
Model: 32-5014-56
·
Zimmer, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00889024458963
- Version / Model
- 32-5014-56
- Catalog Number
- 32-5014-056-00
- Company Name
- Zimmer, Inc.
- Labeler DUNS
- 056038268
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 6
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- 186d317e-ecf1-4408-b67f-48f6b2c955fa
- Distribution End Date
- 2021-09-09
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
- Yes
- 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 |
|---|---|---|---|---|
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46580 | Extra-gynaecological surgical mesh, metal | A non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024458963 | GS1 |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 Inch x 6 Inch |