AccessGUDID - DEVICE: Integra® Miltex® (10381780357636)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 1-242
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1-242
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780357636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Head Mirror

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?
34637	Head reflector	A head-worn device consisting of a circular concave mirror (reflector) attached to a headband designed to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient. The examiner wears the device on his/her head, places the reflector in front of one eye, and views the site through a small hole in the centre of the reflector. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTX	MIRROR, GENERAL & PLASTIC SURGERY

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
Device Size Text, specify: 3-5/8" Outer Diameter

Device Record Status

Public Device Record Key: e343db24-382a-4dc2-83df-1a2c7facc91a
Public Version Date: November 09, 2023
Public Version Number: 4
DI Record Publish Date: September 12, 2018