AccessGUDID - DEVICE: Integra® Miltex® (10381780506089)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 150-57980
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 150-57980
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780506089
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 32
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Casting Wax, GA 28, Green - 32 Pieces Per Box

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:	Yes
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?
16189	Dental casting wax	A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGD	WAX, DENTAL, INTRAORAL

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
Special Storage Condition, Specify: Store in a cool dry location

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 832895eb-82a3-4a0a-9cd6-71c5733ff3c6
Public Version Date: August 03, 2022
Public Version Number: 3
DI Record Publish Date: September 12, 2018