FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGIMESH®EASYPLUG®
DI: 03700296900844
·
Model: TEALFIL-8
·
ASPIDE MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SURGIMESH®EASYPLUG®
- Primary DI
- 03700296900844
- Version / Model
- TEALFIL-8
- Catalog Number
- TEALFIL-8
- Company Name
- ASPIDE MEDICAL
- Labeler DUNS
- 395941714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 7
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 8b98edd0-00ab-48d8-99c6-6eb877334e76
Device Description
Non woven, non knitted reinforcement material made from polypropylene.
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 03700296903838 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 03700296900844 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | WN ø10cm / Alfi 4.5x10cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry