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Sbh

FDA UDI

Class II (US FDA UDI)

by SBH Surgical

Identity

Trade Name
SBH FDA UDI
Generic Name
Electrosurgical handpiece/electrode holder, single-use FDA UDI
Device Name
Single Use, Laparoscopic Metzenbaum Scissor, 5mm tip, 330mm/13" L FDA UDI
Model / Reference
Single Use FDA UDI
Description
Single Use, Laparoscopic Metzenbaum Scissor, 5mm tip, 330mm/13" L FDA UDI

Identifiers

Catalog Number
SBH-1000-34 FDA UDI
Primary DI / UDI-DI
00860011953401 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrosurgical handpiece/electrode holder, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical handpiece/electrode holder, single-use

A comprehensive laparoscopic electrosurgical handpiece for single-use applications. This device is designed to secure an active electrosurgical unit within a sterile operating zone and protect it from adverse events.

Similar devices

Also classified as Electrosurgical handpiece/electrode holder, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SBH Surgical

Sources (1)

  • FDA UDI 2f73b4d8-032b-40db-9a9d-e1beeed60240 35 fields · synced Jul 14, 2026