Identity
- Trade Name
- CompoSeal Mobilea II FDA UDI
- Generic Name
- Basic crimper FDA UDI
- Device Name
- The CompoSeal Mobilea II is intended to be used to seal medical PVC tubing hermetically and create break-off point. FDA UDI
- Model / Reference
- 9027011 FDA UDI
- Description
- The CompoSeal Mobilea II is intended to be used to seal medical PVC tubing hermetically and create break-off point. FDA UDI
Identifiers
- Catalog Number
- 9027011 FDA UDI
- Primary DI / UDI-DI
- 04086000860444 FDA UDI
- FDA Product Code
- GHY FDA UDI
- GMDN Term
- Basic crimper FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic crimper
CompoSeal Mobilea II by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic crimper.
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- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve — Edwards Lifesciences LLC · Class III
- Doctor Nice — B. Ali Impex · Class I
- Doctor Nice — B. Ali Impex · Class I
- EDWARDS CRIMPER — Edwards Lifesciences LLC · Class III
- EDWARDS CRIMPER — Edwards Lifesciences LLC · Class III
- CRIMPER — Edwards Lifesciences LLC · Class III
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
- Fresenius Kabi
Sources (1)
- FDA UDI 2878ad3c-efbe-42c0-a4db-d0b64dc3bf68 35 fields · synced May 30, 2026