Identity
- Trade Name
- Open Soft Tissue Repair Suture Kit-Large FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
- Device Name
- Suture Kit - KIT202 is convenience kit containing HS Fiber sutures (K190817; K153307) and Orthopedic Surgical Needle (HWQ, 510k exempt). FDA UDI
- Model / Reference
- 3910-900-146 FDA UDI
- Description
- Suture Kit - KIT202 is convenience kit containing HS Fiber sutures (K190817; K153307) and Orthopedic Surgical Needle (HWQ, 510k exempt). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840277401410 FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, multifilament FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyolefin/fluoropolymer suture, multifilamentSuturing needle, single-use
Open Soft Tissue Repair Suture Kit-Large by Riverpoint Medical Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing needle, single-use.
- Richard-Allan® Needle 1/2 Circle Taper — Aspen Surgical Products, Inc. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- VOLMED BRASIL — VOLMED BRASIL EQUIPAMENTOS LTDA · Class I
- Richard-Allan® Needle 1/2 Circle Taper — Aspen Surgical Products, Inc. · Class I
- Richard-Allan® Needle 1/2 Circle Reverse Cutting — Aspen Surgical Products, Inc. · Class I
- RC Needle — Biomet Orthopedics, Inc. · Class I
- AROSurgical Vein Vascular Clamp — AROS SURGICAL INSTRUMENTS CORPORATION · Class II
- RC NEEDLE — Biomet Orthopedics, Inc. · Class I
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Riverpoint Medical Llc
Sources (1)
- FDA UDI 3b99b21c-f4d1-45c8-a8a1-06eadd2a75fd 33 fields · synced May 30, 2026