FDA UDI
In Commercial Distribution
🇺🇸 United States
Dextile
DI: 10884521726499
·
Model: DXT1309AR
·
SOFRADIM PRODUCTION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dextile
- Primary DI
- 10884521726499
- Version / Model
- DXT1309AR
- Catalog Number
- DXT1309AR
- Company Name
- SOFRADIM PRODUCTION
- Labeler DUNS
- 576342646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-10
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- fa6155e2-1f89-48d0-8565-92d04d8b10b0
Device Description
Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side
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
- 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 |
|---|---|---|---|---|
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60300 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable | An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. 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 | 10884521726499 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192443 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9 | Centimeter | |
| Width | 13 | Centimeter | |
| Device Size Text, specify | No; |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No;