Identity
- Trade Name
- Dissection Needle FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 1 3/4"(4.3CM), 45 DEGREE TIP FDA UDI
- Model / Reference
- B68010 FDA UDI
- Description
- MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 1 3/4"(4.3CM), 45 DEGREE TIP FDA UDI
Identifiers
- Catalog Number
- B68010 FDA UDI
- Primary DI / UDI-DI
- B089B680100 FDA UDI
- 510(k) Number
- K072124 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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: Open-surgery electrosurgical electrode, monopolar, reusable
Dissection Needle by Black & Black Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.
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- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
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Cleared under the same submission
K072124 also covers:
- B&B Monopolar Dissector — BLACK & BLACK SURGICAL, INC.
- B&B Monopolar Dissector — BLACK & BLACK SURGICAL, INC.
- B&B Monopolar Dissector — BLACK & BLACK SURGICAL, INC.
- Bayonet Monopolar Forceps — BLACK & BLACK SURGICAL, INC.
- Bipolar Cord — BLACK & BLACK SURGICAL, INC.
- Bipolar Cord — BLACK & BLACK SURGICAL, INC.
- Bipolar Cord — BLACK & BLACK SURGICAL, INC.
- Bipolar Cord — BLACK & BLACK SURGICAL, INC.
- Bipolar Cord — BLACK & BLACK SURGICAL, INC.
- Dissection Needle — BLACK & BLACK SURGICAL, INC.
- Dissection Needle — BLACK & BLACK SURGICAL, INC.
- Dissection Needle — BLACK & BLACK SURGICAL, 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
- Black & Black Surgical, Inc.
Sources (1)
- FDA UDI 449cf536-5459-4bd8-bbe1-28bcc4399d8b 36 fields · synced May 30, 2026