Identity
- Trade Name
- SafeSheath® II FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Hemostatic Tear-away Introducer, 9F FDA UDI
- Model / Reference
- SSCL9 FDA UDI
- Description
- Hemostatic Tear-away Introducer, 9F FDA UDI
Identifiers
- Catalog Number
- SSCL9 FDA UDI
- Primary DI / UDI-DI
- 10885672012691 FDA UDI
- 510(k) Number
- K122084 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
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: Vascular catheter introduction set, nonimplantable
SafeSheath® II by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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Cleared under the same submission
K122084 also covers:
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
- Adelante SafeSheath II — Oscor Inc.
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
- Oscor Inc.
Sources (1)
- FDA UDI c8b50340-b9d4-4551-97eb-dc8d7505253a 37 fields · synced Jun 1, 2026