FDA UDI
In Commercial Distribution
🇺🇸 United States
ProSup
DI: 10884521177611
·
Model: TECLGK01
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProSup
- Primary DI
- 10884521177611
- Version / Model
- TECLGK01
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-06
- Public Version
- 6
- Public Version Date
- 2025-06-24
- Public Version Status
- Update
- Public Device Record Key
- c625d419-6f04-4cb7-a6ef-6a30754b38d0
Device Description
Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 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
- 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 |
|---|---|---|---|---|
| 60842 | Pelvic organ prolapse surgical mesh, synthetic polymer | A sterile woven/knitted or porous material comprised of a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521177611 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982532 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 15 | Centimeter |