Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port FDA UDI
- Model / Reference
- IPN000139 FDA UDI
- Description
- Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port FDA UDI
Identifiers
- Catalog Number
- CL-07690 FDA UDI
- Primary DI / UDI-DI
- 00801902001870 FDA UDI
- 510(k) Number
- K862056 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument guard, single-use
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument guard, single-use.
- Oxboro ™ DuoGuard™ Instrument Tip Protectors — Aspen Surgical Products, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Oxboro ™ Osteotome Tip Protectors — Aspen Surgical Products, Inc. · Class I
- Simpulse — Davol Inc. · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Steri-Pocket — Hanes Companies, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Oxboro ™ Instrument Tip Protectors — Aspen Surgical Products, Inc. · Class I
Cleared under the same submission
K862056 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI da54f20a-465d-4c1a-83c1-44ac51e80aa3 36 fields · synced May 30, 2026