AccessGUDID - DEVICE: Integra® Miltex® (10381780438182)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 70-184
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-184
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780438182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Plastic Filling Instrument 6-1/2", No. 5, Double Ended, Octagonal Handle

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?
65077	Dental restoration carver, multiple-material	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in multiple dental restoration materials such as amalgam, cement, and acrylic or composite resin/plastic (i.e., not dedicated to a particular material) by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It is typically a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL

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
Device Size Text, specify: 6-1/2"

Device Record Status

Public Device Record Key: 337fa35f-6c7b-4e6b-896e-5a5225a2c706
Public Version Date: April 28, 2023
Public Version Number: 7
DI Record Publish Date: January 24, 2018