AccessGUDID - DEVICE: Integra® Miltex® (10381780501602)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 700511-8500-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 700511-8500-001
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780501602
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 2500
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Endo Stop Dispenser - Silicone, White, Package of 2,500

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?
45123	Endodontic stopper	A device that is used as a measuring reference point on an endodontic instrument used in a root canal procedure. It is typically designed as a flat ring made of an elastic material (e.g., silicone) that is placed at a predetermined distance from the distal end of the instrument (e.g., an endodontic file) allowing the operator to gauge the maximum depth of penetration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKS	FILE, PULP CANAL, 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: 96c77623-31ee-4633-b884-a6ebf9a087e7
Public Version Date: July 21, 2020
Public Version Number: 3
DI Record Publish Date: September 18, 2018