AccessGUDID - DEVICE: Integra® Miltex® (10381780417538)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 18-658
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-658
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780417538
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Jameson Caliper 4", Graduated from 0 to 80mm in 1mm increments

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?
35787	Ophthalmic calliper	A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOE	Caliper, ophthalmic

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 54c041fb-0acf-443f-84f7-8a4b925cebde
Public Version Date: April 27, 2023
Public Version Number: 4
DI Record Publish Date: December 21, 2017