AccessGUDID - DEVICE: Integra® Miltex® (10381780415145)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: V940251
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V940251
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780415145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Tissue Nipper, 5", Convex Jaws

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?
12695	Nail clippers, reusable	A hand-held device designed specifically for trimming the nails of a patient. Also known as a nail cutter, it is a robust instrument comprised of two hinged cutting blades that are conjoined at the handle end of the device. The blades are sprung to hold them apart when not activated; when activated, the two blades are pressed together in a chopping motion to bite off (clip) the nail that has been positioned between them. It is not a pair of nail scissors. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: 0a77dd76-91ea-469d-91b4-c332496a12ec
Public Version Date: May 02, 2023
Public Version Number: 5
DI Record Publish Date: December 18, 2017