AccessGUDID - DEVICE: UltraLite® (10381780168850)

GUDID

Device Identifier (DI) Information

Brand Name: UltraLite®
Version or Model: AX2100BIF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AX2100BIF
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780168850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: Integra® UltraLite® Pro headlight with 9 ft. premium bifurcated cable, Headlight Module and Gownclips

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?
32037	General-purpose light source	A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FST	LIGHT, SURGICAL, FIBEROPTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864380	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: 084f9e78-63b2-48ab-9491-7200e6eefa91
Public Version Date: May 16, 2023
Public Version Number: 9
DI Record Publish Date: September 07, 2016