AccessGUDID - DEVICE: Integra® Miltex® (10381780424130)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 21-627
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-627
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780424130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Ruskin Bone Cutting Forceps 5-5/8", 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?
46688	Bone cutting forceps, reusable	A strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTZ	INSTRUMENT, CUTTING, ORTHOPEDIC

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: 5-5/8"

Device Record Status

Public Device Record Key: 0a968612-9578-4501-b673-2df29eb60d51
Public Version Date: October 18, 2023
Public Version Number: 7
DI Record Publish Date: January 10, 2018