AccessGUDID - DEVICE: Integra® Miltex® (10381780414407)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 76D-W8A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76D-W8A
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780414407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Dental Dam clamp, Style W8A

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?
15712	Rubber dam clamp	A dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EEF	CLAMP, RUBBER DAM

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 194a6063-4c46-4111-a9a8-ee227a7a7a05
Public Version Date: March 06, 2024
Public Version Number: 7
DI Record Publish Date: December 21, 2017