FDA UDI
In Commercial Distribution
🇺🇸 United States
MeshgraftTM II Tissue Expansion System
DI: 00889024372573
·
Model: 00-2195-014-00
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MeshgraftTM II Tissue Expansion System
- Primary DI
- 00889024372573
- Version / Model
- 00-2195-014-00
- Catalog Number
- 00-2195-014-00
- Company Name
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 137354267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 1
- Public Version Date
- 2020-10-01
- Public Version Status
- New
- Public Device Record Key
- 0a59ecea-56a9-4adb-aa7c-bd901614d012
Device Description
6 TO 1 DERMACARRIER
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
- Yes
- 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 |
|---|---|---|---|---|
| FZW | Expander, Surgical, Skin Graft | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47924 | Skin graft carrier | A sterile device in the form of a flat, rectangular plate designed to support a skin graft (a section of donor skin from another part of a patient's body) while the graft is being perforated in a skin graft mesher in preparation for grafting to the treatment site. It is typically made of disposable plastic material. The carrier is also used to transfer the perforated graft from the mesher to the grafting site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024372573 | GS1 | ||||
| Package | 00889024378797 | GS1 | Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 n to 1 in Expansion Ratio |