AccessGUDID - DEVICE: Integra® Miltex® (10381780363125)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 18-398
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-398
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780363125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Magnetic Eye Probel, With Foreign Body Loop

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?
46718	Eye magnet, non-powered	A non-electric hand-held instrument designed to generate a magnetic field intended to locate and remove metallic foreign bodies [typically those containing iron (Fe) or steel] from eye tissue; it may include a wire loop at one end for mechanical extraction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPN	Magnet, permanent

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
No Device Sizes

Device Record Status

Public Device Record Key: 015a31d7-0e47-4a2f-88fd-a4f9fe5eed2d
Public Version Date: April 28, 2023
Public Version Number: 4
DI Record Publish Date: September 12, 2018