AccessGUDID - DEVICE: Integra® Miltex® (10381780174868)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: PN2SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PN2SS
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780174868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: N-Tralig® Intraligamentary Syringe Cartridge Barrel, Solid Wall

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?
35969	Dental anaesthesia syringe, reusable	A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJI	SYRINGE, CARTRIDGE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142414	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 2-5/8"
Outer Diameter: 11 Millimeter

Device Record Status

Public Device Record Key: 33b5d050-7643-42fc-a742-57b844b565ea
Public Version Date: August 08, 2023
Public Version Number: 8
DI Record Publish Date: August 16, 2016