Identity
- Trade Name
- AeroStat® FDA UDI
- Generic Name
- Cholangiography catheter FDA UDI
- Device Name
- Indicated for use during open and laparoscopic cholecystectomy procedures to inject radiopaque media through the cystic duct into the biliary tree. FDA UDI
- Model / Reference
- C1002 FDA UDI
- Description
- Indicated for use during open and laparoscopic cholecystectomy procedures to inject radiopaque media through the cystic duct into the biliary tree. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915116682 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Cholangiography catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Centimeter FDA UDICatheter Gauge — 3 French FDA UDI
Category: Cholangiography catheter
AeroStat® by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cholangiography catheter.
- SpyGlass™ Discover — Boston Scientific · 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
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 97b97324-9e73-496c-b1fa-8593433a3d21 35 fields · synced May 29, 2026