FDA UDI
In Commercial Distribution
🇺🇸 United States
Gentrix®
DI: 00386190001790
·
Model: PSMT1620A
·
ACELL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gentrix®
- Primary DI
- 00386190001790
- Version / Model
- PSMT1620A
- Catalog Number
- PSMT1620
- Company Name
- ACELL, INC.
- Labeler DUNS
- 137258252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-04
- Public Version
- 10
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 159d81d9-5d11-4678-9bbd-ccb4f2ee2506
Device Description
Gentrix® Surgical Matrix Thick 16 x 20 cm
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
| OXK | Mesh, surgical, collagen, large abdominal wall defects | General, Plastic Surgery | 878.3300 | 2 |
| OXH | Mesh, surgical, collagen, plastic and reconstructive surgery | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial | A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. 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 | 00386190001790 | GS1 |
Customer Contacts
- Phone
- +1(800)826-2926
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 16 | Centimeter | |
| Length | 20 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean, dry environment at room temperature