Identity
- Trade Name
- Atala-Shepard FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- Atala-Shepard Coaxial Balloon Follower With AQ, Hydrophilic Long Taper Urethral Dilators FDA UDI
- Model / Reference
- G17612 FDA UDI
- Description
- Atala-Shepard Coaxial Balloon Follower With AQ, Hydrophilic Long Taper Urethral Dilators FDA UDI
Identifiers
- Catalog Number
- 118116-OW-AQ-DIL FDA UDI
- Primary DI / UDI-DI
- 00827002176126 FDA UDI
- FDA Product Code
- KOE FDA UDI
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5520 FDA UDI
- Commercial Distribution
- Not 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
Atala-Shepard by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 Incorporated
Sources (1)
- FDA UDI c41c75c5-61d3-4d79-95d1-4eb94fc08a56 37 fields · synced Jun 8, 2026