AccessGUDID - DEVICE: Integra® Miltex® (10381780505952)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 013-31200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 013-31200
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780505952
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: Pulp Canal Aspirator Tips, Set of 3, Small, Large, Extra Large

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:	Yes
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?
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHZ	Evacuator, oral cavity

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: 9ec1d1cb-01ec-47c6-8d4c-4e0bd9bbad27
Public Version Date: July 18, 2022
Public Version Number: 3
DI Record Publish Date: September 12, 2018