Identity
- Trade Name
- Wiggins Medical FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- Black Bayonet Kerrison, straight, 40° up, standard footplate, 5mm, 7" WL FDA UDI
- Model / Reference
- 52-610-05B FDA UDI
- Description
- Black Bayonet Kerrison, straight, 40° up, standard footplate, 5mm, 7" WL FDA UDI
Identifiers
- Catalog Number
- 52-610-05B FDA UDI
- Primary DI / UDI-DI
- 00840217903073 FDA UDI
- 510(k) Number
- K200383 FDA UDI
- FDA Product Code
- HAE FDA UDI
- GMDN Term
- Spinal rongeur 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 7 Inch FDA UDIWidth — 5 Millimeter FDA UDI
Category: Spinal rongeur
Wiggins Medical by Ebner Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal rongeur.
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Cleared under the same submission
K200383 also covers:
- Ace Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
- Wiggins Medical — EBNER MEDICAL LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ebner Medical Llc
Sources (1)
- FDA UDI 8dd70cc0-8563-47f8-85b7-ce498af210f1 37 fields · synced May 30, 2026