AccessGUDID - DEVICE: Integra® Miltex® (10381780502838)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 9-124
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9-124
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780502838
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Wire Cutting Scissors, 4-3/4", Angled To Side, One Serrated Blade

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?
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRW	SCISSORS, GENERAL, SURGICAL
EIR	SCISSORS, COLLAR AND CROWN

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
Device Size Text, specify: 4-3/4"

Device Record Status

Public Device Record Key: e901f4c9-a61b-4ebd-ac86-837dda96efba
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: October 01, 2020