AccessGUDID - DEVICE: Integra® Miltex® (10381780484585)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 012-S4062
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 012-S4062
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780484585
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: Flex-R® Files - Flexible Roane Tip w/Stop #10 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:	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?
63720	Manual endodontic file/rasp, single-use	A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. 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: 1957e39e-2091-4564-a5ab-68d58987f6f5
Public Version Date: July 18, 2022
Public Version Number: 6
DI Record Publish Date: July 03, 2018