AccessGUDID - DEVICE: Integra® Miltex® (10381780362746)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 18-1962
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-1962
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780362746
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® West Lacrimal Sac Chisel, 6-1/4", 4mm Wide Blade, Straight

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?
10827	Mastoid chisel	A single-bladed, surgical instrument, bevelled on one side with a flat cutting edge that is used to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZO	CHISEL, SURGICAL, MANUAL

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
Width: 4 Millimeter
Device Size Text, specify: 4.9mm Wide Blade
Device Size Text, specify: 6-1/4"

Device Record Status

Public Device Record Key: 343edbed-bcd0-4e49-a40e-6b230377908c
Public Version Date: November 19, 2024
Public Version Number: 8
DI Record Publish Date: June 28, 2017