Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Pelvic examination kit FDA UDI
- Device Name
- PAP SMEAR KIT FDA UDI
- Model / Reference
- PE3430A FDA UDI
- Description
- PAP SMEAR KIT FDA UDI
Identifiers
- Catalog Number
- PE3430A FDA UDI
- Primary DI / UDI-DI
- 10193489196610 FDA UDI
- FDA Product Code
- MLT FDA UDI
- GMDN Term
- Pelvic examination kit 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Pelvic examination kit
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Centurion — Centurion Medical Products · Class II
- Centurion — Centurion Medical Products · Class II
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 61a0168b-5b46-4cb5-a810-583b596f4ec7 35 fields · synced May 30, 2026