Identity
- Trade Name
- Custom Medical Specialties, Inc. FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- Small Vaginal Speculum - Sterile FDA UDI
- Model / Reference
- CMS-2076 FDA UDI
- Description
- Small Vaginal Speculum - Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815849021679 FDA UDI
- FDA Product Code
- HIB FDA UDI
- GMDN Term
- Vaginal speculum, single-use FDA UDI
Classification
- Device Class
- Class II 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal speculum, single-use
Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Custom Assemblies, Inc.
Sources (1)
- FDA UDI 22e5c92b-ed7d-4c36-a62d-da16e6ac7b38 33 fields · synced May 30, 2026