AccessGUDID - DEVICE: Integra® Miltex® (10381780496755)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 71-96
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71-96
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780496755
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Amalgam Well, Round Bottom

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?
35867	Dental amalgam well	A small cup where mixed amalgam is put before being taken up by an amalgam carrier or an amalgam syringe. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKI	CARRIER, AMALGAM, OPERATIVE

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: 9cae4714-bb5c-40f1-9c03-0751bc4b4d2b
Public Version Date: July 20, 2022
Public Version Number: 3
DI Record Publish Date: October 24, 2018