AccessGUDID - DEVICE: Integra® Miltex® (10381780203438)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 61-20
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 61-20
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780203438
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: Curette, Molt 2-4, Double-Ended, Round Handle

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?
41660	Periodontal curette	A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMS	CURETTE, PERIODONTIC

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: b733ac6b-6b7d-47e4-b4e9-6c826614b2d3
Public Version Date: July 15, 2022
Public Version Number: 5
DI Record Publish Date: August 16, 2018