AccessGUDID - DEVICE: Integra® Miltex® (10381780385219)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: TF34-KK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TF34-KK
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780385219
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Condenser, Amalgam, 3mm-4mm, Black, Tactile Tone™

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?
16460	Dental amalgam condenser, reusable	A hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKG	CONDENSER, AMALGAM AND FOIL, 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: 37f4541d-d270-4618-ad27-e60f103acf5e
Public Version Date: October 28, 2020
Public Version Number: 4
DI Record Publish Date: April 19, 2018