Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Device Name
- Vaginal Speculum Fiber Optic Large w/ Sheath FDA UDI
- Model / Reference
- KI103SH/20 FDA UDI
- Description
- Vaginal Speculum Fiber Optic Large w/ Sheath FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094103181 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal speculum, single-use
Bioseal Inc. by Bioseal — 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
- Bioseal
Sources (1)
- FDA UDI 62514e05-6dcc-4f1e-95c4-0f8c4789bfb8 33 fields · synced Jun 6, 2026