FDA UDI
In Commercial Distribution
🇺🇸 United States
XenMatrix AB Surgical Graft
DI: 00801741129049
·
Model: 1153045
·
Davol Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XenMatrix AB Surgical Graft
- Primary DI
- 00801741129049
- Version / Model
- 1153045
- Catalog Number
- 1153045
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-08
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0cbeb5cb-a828-4534-891c-9cd6d35295d3
Device Description
XenMatrix AB Surgical Graft
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| OXH | Mesh, surgical, collagen, plastic and reconstructive surgery | General, Plastic Surgery | 878.3300 | 2 |
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
| PIJ | Collagen surgical mesh containing drugs | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61107 | Abdominal hernia surgical mesh, collagen, antimicrobial | A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it includes a pharmaceutical antibacterial agent. It may also be used as a short-term scaffold for tissue regeneration; it is not designed specifically for diaphragmatic hernia repair and has no extra-abdominal applications. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741129049 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 45 | Centimeter | |
| Length | 30 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 30 Degrees Celsius