Identity
- Trade Name
- mityhook FDA UDI
- Generic Name
- Amniotome, single-use FDA UDI
- Device Name
- mityhook amniotome - a sterile amniotome to rupture the amniotic membrane FDA UDI
- Model / Reference
- 10035 FDA UDI
- Description
- mityhook amniotome - a sterile amniotome to rupture the amniotic membrane FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937014761 FDA UDI
- FDA Product Code
- HGE FDA UDI
- GMDN Term
- Amniotome, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Amniotome, single-use
mityhook by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amniotome, single-use.
- MedGyn Disposable Amnio Hook — MEDGYN PRODUCTS, INC. · Class I
- AROM-COT — Utah Medical Products, Inc. · Class I
- AROM-COT — Utah Medical Products, 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 I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI e8d816ec-6469-4021-9485-48712109beb3 33 fields · synced Jun 9, 2026