Identity
- Trade Name
- GORE DRYSEAL FLEX Introducer Sheath FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- GORE DRYSEAL FLEX Introducer Sheath 33cm 11Fr Hydrophilic Coating FDA UDI
- Model / Reference
- DSF1133 FDA UDI
- Description
- GORE DRYSEAL FLEX Introducer Sheath 33cm 11Fr Hydrophilic Coating FDA UDI
Identifiers
- Catalog Number
- DSF1133 FDA UDI
- Primary DI / UDI-DI
- 00733132629985 FDA UDI
- 510(k) Number
- K160254 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 11 French FDA UDILength — 33 Centimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
GORE DRYSEAL FLEX Introducer Sheath by W. L. Gore & Associates, 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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- ARROW — TELEFLEX INCORPORATED · Class II
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Cleared under the same submission
K160254 also covers:
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, INC
- GORE DRYSEAL FLEX Introducer Sheath — W. L. GORE & ASSOCIATES, 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
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 7aaa4e71-61bb-4499-93ce-cb3e537cf604 37 fields · synced May 30, 2026