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Needle Holder Insert

FDA UDI

Class II (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
NEEDLE HOLDER INSERT FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
Device Name
NEEDLE HOLDER WITH TUNGSTEN CARBIDE SERRATED CROSS-WISE TEETH STRAIGHT SINGLE-ACTION JAW FOR TUBE SHAFT FDA UDI
Model / Reference
2901-321S FDA UDI
Description
NEEDLE HOLDER WITH TUNGSTEN CARBIDE SERRATED CROSS-WISE TEETH STRAIGHT SINGLE-ACTION JAW FOR TUBE SHAFT FDA UDI

Identifiers

Primary DI / UDI-DI
B0992901321S0 FDA UDI
510(k) Number
K102921 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 330 Millimeter FDA UDI

Needle Holder Insert by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102921 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI 60686d28-8f9a-4aff-8d46-7876ea114397 37 fields · synced May 31, 2026