← Back to catalogue

Accu-Beam

FDA UDI

Class II (US FDA UDI)

by Transamerican Technologies International

Identity

Trade Name
Accu-Beam FDA UDI
Generic Name
Laparoscope laser coupler FDA UDI
Device Name
Wolf Endo-Adaptor 8mm with direct coupler. FDA UDI
Model / Reference
3113WOL8 FDA UDI
Description
Wolf Endo-Adaptor 8mm with direct coupler. FDA UDI

Identifiers

Primary DI / UDI-DI
B1773113WOL80 FDA UDI
510(k) Number
K870046 FDA UDI
FDA Product Code
HHR FDA UDI
GMDN Term
Laparoscope laser coupler FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4550 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Laparoscope laser coupler

Accu-Beam by Transamerican Technologies International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscope laser coupler.

Cleared under the same submission

K870046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Transamerican Technologies International

Sources (1)

  • FDA UDI a4c2b99a-82d1-4c57-af48-9e9e7b518fa3 34 fields · synced Jun 9, 2026