Identity
- Trade Name
- Flipper FDA UDI
- Generic Name
- Embolization implant inserter FDA UDI
- Device Name
- Flipper, Delivery System FDA UDI
- Model / Reference
- G12912 FDA UDI
- Description
- Flipper, Delivery System FDA UDI
Identifiers
- Catalog Number
- FDW-35-80 FDA UDI
- Primary DI / UDI-DI
- 00827002129122 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Embolization implant inserter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 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
MR Conditional FDA UDI
Category: Embolization implant inserter
Flipper by William Cook Europe ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Embolization implant inserter.
- Coil Pusher-16 — Boston Scientific · Class II
- Flipper — William Cook Europe ApS · 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
- William Cook Europe ApS
Sources (1)
- FDA UDI 5e00ce23-8e14-4d03-9442-bc4b76a2a141 36 fields · synced Jun 8, 2026