Identity
- Trade Name
- Amplatz FDA UDI
- Generic Name
- Fascial tissue dilator, single-use FDA UDI
- Device Name
- Amplatz Renal Dilator Set FDA UDI
- Model / Reference
- G14485 FDA UDI
- Description
- Amplatz Renal Dilator Set FDA UDI
Identifiers
- Catalog Number
- 075000-S1 FDA UDI
- Primary DI / UDI-DI
- 00827002144859 FDA UDI
- FDA Product Code
- KOE FDA UDI
- GMDN Term
- Fascial tissue dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5520 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
Amplatz by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, single-use.
- Byrd — COOK VANDERGRIFT INC. · Class I
- Dilator — GALT MEDICAL CORP. · Class IIa
- VisiSheath Dilator Sheath — Spectranetics Corporation · Class III
- Dilator — GALT MEDICAL CORP. · Class IIa
- Vessel Dilator — Argon Medical Devices, Inc. · Class II
- Evolution — COOK VANDERGRIFT INC. · Class II
- VisiSheath Dilator Sheath — Spectranetics Corporation · Class III
- Byrd — COOK VANDERGRIFT INC. · Class I
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 b440a9c8-13db-4a56-940e-546d549ad840 36 fields · synced Jun 6, 2026