Identity
- Trade Name
- Collins Speculum Medium FDA UDI
- Generic Name
- Vaginal speculum, reusable FDA UDI
- Device Name
- Collins Speculum Medium 1 3/8" x 4" (35mm x 102mm) FDA UDI
- Model / Reference
- Collins Speculum Medium 1 3/8" x 4" (35mm x 102mm) FDA UDI
- Description
- Collins Speculum Medium 1 3/8" x 4" (35mm x 102mm) FDA UDI
Identifiers
- Catalog Number
- 030947 FDA UDI
- Primary DI / UDI-DI
- M803030947 FDA UDI
- FDA Product Code
- HDF FDA UDI
- GMDN Term
- Vaginal speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4520 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Vaginal speculum, reusable
Collins Speculum Medium by Medgyn Products, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medgyn Products, Inc.
Sources (1)
- FDA UDI 34a64f47-fc25-436c-9c89-b58e56552075 34 fields · synced Jun 1, 2026