Identity
- Trade Name
- Kwik Kleen FDA UDI
- Generic Name
- Bone punch, reusable FDA UDI
- Device Name
- Kerrison 1mm x 180mm, 40 Degree FDA UDI
- Model / Reference
- 8527-00 FDA UDI
- Description
- Kerrison 1mm x 180mm, 40 Degree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657021289 FDA UDI
- 510(k) Number
- K023868 FDA UDI
- FDA Product Code
- HAE FDA UDI
- GMDN Term
- Bone punch, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4840 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone punch, reusable
Kwik Kleen by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone punch, reusable.
- Quick Release — Vitalitec International Medizintechnik GmbH · Class II
- Quick Release — Vitalitec International Medizintechnik GmbH · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Quick Release — Vitalitec International Medizintechnik GmbH · Class II
- Quick Release — Vitalitec International Medizintechnik GmbH · Class II
- Punch — SOPRO-COMEG GmbH · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Quick Release — Vitalitec International Medizintechnik GmbH · Class II
Cleared under the same submission
K023868 also covers:
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Kwik Kleen — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Kwik Kleen — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Kwik Kleen — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Kwik Kleen — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Kwik Kleen — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 48bdaab8-c180-4322-8264-cb989a1ff412 34 fields · synced Jun 8, 2026