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Axial Handle

FDA UDI

Class II (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
Axial Handle FDA UDI
Generic Name
Laparoscopic surgery handle FDA UDI
Device Name
Axial Handle Angled With Spring And Ratchet For 3 Millimeter, 5 Millimeter, and 10 Millimeter Diameter Tube Shafts FDA UDI
Model / Reference
2901-082 FDA UDI
Description
Axial Handle Angled With Spring And Ratchet For 3 Millimeter, 5 Millimeter, and 10 Millimeter Diameter Tube Shafts FDA UDI

Identifiers

Catalog Number
2901-082 FDA UDI
Primary DI / UDI-DI
00192896115774 FDA UDI
510(k) Number
K102921 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Laparoscopic surgery handle 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laparoscopic surgery handle

Axial Handle by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic surgery handle.

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 1da02ddf-c168-4180-83ff-193783f2b9e0 36 fields · synced May 30, 2026