AccessGUDID - DEVICE: Integra® Miltex® (10381780363293)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 18-446
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-446
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780363293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Jameson Strabismus Hook 5", 11mm hook

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?
12036	Eye muscle hook, reusable	A hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNQ	Hook, 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
Device Size Text, specify: 11mm hook
Length: 5 Inch

Device Record Status

Public Device Record Key: 6a511b5d-4b39-4097-b3bd-c8ed8c46b974
Public Version Date: April 28, 2023
Public Version Number: 10
DI Record Publish Date: June 28, 2017