Identity
- Trade Name
- Steady Sheath FDA UDI
- Generic Name
- Fascial tissue dilator, single-use FDA UDI
- Device Name
- SteadySheath Shortie 9 Fr Evolution Tissue Stabilization Sheath FDA UDI
- Model / Reference
- G31908 FDA UDI
- Description
- SteadySheath Shortie 9 Fr Evolution Tissue Stabilization Sheath FDA UDI
Identifiers
- Catalog Number
- LR-TSS-SH-9.0 FDA UDI
- Primary DI / UDI-DI
- 00827002319080 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Fascial tissue dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 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: Fascial tissue dilator, single-use
Steady Sheath by Cook Vandergrift Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, single-use.
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- Dilator — GALT MEDICAL CORP. · Class IIa
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- Dilator — GALT MEDICAL CORP. · Class IIa
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Byrd — COOK INCORPORATED · Class II
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
- Cook Vandergrift Inc.
Sources (1)
- FDA UDI bd6f5865-9791-41b2-9e3d-e10ff2317bb1 36 fields · synced May 30, 2026