Identity
- Trade Name
- VAGISPEC KOLPLAST FDA UDI
- Generic Name
- Vaginal speculum, single-use FDA UDI
- Model / Reference
- ESPEC VAG KOLPLAST G LONGO EST FDA UDI
Identifiers
- Catalog Number
- 10.1330 FDA UDI
- Primary DI / UDI-DI
- 07898027902161 FDA UDI
- 510(k) Number
- K973853 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal speculum, single-use
Vagispec Kolplast by Kolplast CI SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vaginal speculum, single-use.
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Cleared under the same submission
K973853 also covers:
- KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
- VAGISPEC KOLPLAST — Kolplast CI SA
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
- Kolplast CI SA
Sources (1)
- FDA UDI 42a8cc57-aa22-4a11-b086-bfdfec8c621c 34 fields · synced Jun 6, 2026