AccessGUDID - DEVICE: Integra® Miltex® (10381780479796)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 012-14905
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 012-14905
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780479796
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Onyx-Flex™ Spreaders M 25mm

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?
17890	Endodontic filling material condenser	A dental instrument that uses heat to condense an endodontic filling material in a root canal, in the axial/lateral direction. The working part is typically cylindrical or tapered, and circular in cross-section. A condenser is commonly used to function as a plugger or spreader. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKK	SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

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: 6b448ab9-0443-458d-97e7-48287a56c5b6
Public Version Date: July 14, 2022
Public Version Number: 3
DI Record Publish Date: July 03, 2018