Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Cervical cytology brush FDA UDI
- Device Name
- STERL SKLAR CERVIX BRUSH 100BX FDA UDI
- Model / Reference
- 96-4140 FDA UDI
- Description
- STERL SKLAR CERVIX BRUSH 100BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50649111303539 FDA UDI
- 510(k) Number
- K001119 FDA UDI
- FDA Product Code
- HHT FDA UDI
- GMDN Term
- Cervical cytology brush 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical cytology brush
Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical cytology brush.
- Papette — Andwin Scientific · Class II
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- Andwin Scientific — Andwin Scientific · Class II
- C60100 — B&B Company Co., Ltd. · Class II
- C60100 — B&B Company Co., Ltd. · Class II
- Andwin Scientific — Andwin Scientific · Class II
- SoftBiopsy — HISTOLOGICS LLC · Class I
- Papette — CooperSurgical, Inc. · Class II
Cleared under the same submission
K001119 also covers:
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C.
- Rovers® EndoCervex-Brush® — Rovers Medical Devices B.V.
- Rovers® EndoCervex-Brush® — Rovers Medical Devices B.V.
- Rovers® EndoCervex-Brush®-S — Rovers Medical Devices B.V.
- Rovers® EndoCervex-Brush®-S RT — Rovers Medical Devices B.V.
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
- Sklar Corporation
Sources (1)
- FDA UDI 07dc0f63-239d-4130-a627-0c958b3faca7 34 fields · synced Jun 8, 2026