AccessGUDID - DEVICE: Accu-Beam (B17711180)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Beam
Version or Model: 1118
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Primary DI Number: B17711180
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130213366 *Terms of Use

Device Description: Ellman Laser Thread Adapter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Laser adaptor	A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Laser adaptor

A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HHR	Laser, Surgical, Gynecologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864378	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc4c5941-6d3f-4797-97b1-da57245dde63
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 08, 2016