Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Intrauterine device removal hook, reusable FDA UDI
- Device Name
- Simple IUD Hook, Malleable, 4mm, 25.5cm FDA UDI
- Model / Reference
- 280-801 FDA UDI
- Description
- Simple IUD Hook, Malleable, 4mm, 25.5cm FDA UDI
Identifiers
- Catalog Number
- 280-801 FDA UDI
- Primary DI / UDI-DI
- 00840306806780 FDA UDI
- FDA Product Code
- HHF FDA UDI
- GMDN Term
- Intrauterine device removal hook, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Intrauterine device removal hook, reusable
Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Gynex — GYNEX CORPORATION · Class I
- Gynex — GYNEX CORPORATION · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Marina Medical Instruments, Inc.
Sources (1)
- FDA UDI 747daa3f-7f66-40fb-9226-f5e2e6d2d6f2 35 fields · synced Jun 8, 2026