AccessGUDID - DEVICE: Integra® Duo (10381780490715)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Duo
Version or Model: 90642
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90642
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780490715
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: Integra® Duo Duo Headband One Replacement Pad Set

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
FSR	Light, headband, surgical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 3d400a5e-fe9c-4522-8589-e11d36ec8e4e
Public Version Date: February 04, 2025
Public Version Number: 7
DI Record Publish Date: November 14, 2018