AccessGUDID - DEVICE: AcuPulse™ Incisional Handpiece 125 mm (07290109141527)

GUDID

Device Identifier (DI) Information

Brand Name: AcuPulse™ Incisional Handpiece 125 mm
Version or Model: AcuPulse™ Incisional Handpiece 125 mm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AA0632600
Company Name: LUMENIS LTD.

Primary DI Number: 07290109141527
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 600166524 *Terms of Use

Device Description: Additional DM DIs: 07290109144016 07290109144023 07290109144030

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63306	Surgical laser system beam-focus handpiece	A noninvasive hand-held device intended to be connected to the beam guide of a surgical laser system to focus the laser beam during delivery to the target tissue. It is in the form of a rigid cylinder with integrated lenses which focus laser beam wavelengths for surgical applications. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 125 Millimeter

Device Record Status

Public Device Record Key: 6c2964c5-b10d-43f7-b49c-4f56a798201a
Public Version Date: December 18, 2023
Public Version Number: 6
DI Record Publish Date: August 28, 2016