AccessGUDID - DEVICE: Integra® Miltex® (10381780362517)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 18-171
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-171
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780362517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Castroviejo Blade Breaker and Holder, 5-3/8", 12mm Smooth Jaws, Round Handle, With Lock

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?
44959	Razor blade breaker/holder	A surgical instrument specially designed to be used to break, breakable razor blades into shards of extremely sharp segments. Once this is done the instrument can then be used as a safety holder for the segment of broken razor blade, acting as a handle, whilst the surgeon uses it like a scalpel to cut tissue. When the operation is completed the segment of blade is disposed of. Some physicians prefer this method which guarantees the sharpness of the cutting edge. This device is made of high quality stainless-steel alloy and is designed like a short-nosed plier with a locking device to lock the blade segment securely in place. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNN	Knife, ophthalmic

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
Length: 12 Millimeter
Device Size Text, specify: 5-3/8"

Device Record Status

Public Device Record Key: 0cb44e7c-b27a-4d24-b7cc-dc1c96d02ec5
Public Version Date: April 27, 2023
Public Version Number: 4
DI Record Publish Date: September 12, 2018