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FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir
FDA UDIClass II (US FDA UDI)
by T.a.g Medical Products Agricultural Cooperative Association
Identity
- Trade Name
- FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
- Model / Reference
- AR-4570R FDA UDI
Identifiers
- Catalog Number
- 173000ar FDA UDI
- Primary DI / UDI-DI
- 10818674025697 FDA UDI
- 510(k) Number
- K190125 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Soft-tissue/mesh anchor, non-bioabsorbable
FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir by T.a.g Medical Products Agricultural Cooperative Association — Class II…
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Cleared under the same submission
K190125 also covers:
- FiberStitch™ Implant - Curved RC — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant - Straight RC — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, 24° Curved with two Polyester Implants and 2-0 FiberWi — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, 24°Curved with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Curved (RC) with two Polyester Implants and 2-0 Fibe — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire® — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 Fib — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 Fib — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Straight (RC) with two Polyester Implants and 2-0 Fibe — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 Fibe — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 FiberWire — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 73777c95-4fe5-4ac0-afe6-a7fd3c51559d 34 fields · synced May 30, 2026