AccessGUDID - DEVICE: Integra® Miltex® (10381780509387)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 33-234
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33-234
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780509387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Miltex® Replacement Drill Points Miltex Nail drill set of 3

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?
11337	Fingernail drill bit	A shaft of metal designed to penetrate a fingernail or toenail to access the underlying tissue, typically to relieve pressure from a subungual haematoma (release of blood/fluid accumulated in the underlying nail bed). It is inserted into an appropriate drilling device and typically has a ball-shaped cutting head that, when rotated, cuts through the tissue of the nail. It is available with various cutting head shapes and sizes. 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: 7a5ec1c0-3dab-45ec-8723-6fd636a1647c
Public Version Date: May 15, 2023
Public Version Number: 3
DI Record Publish Date: October 23, 2018