AccessGUDID - DEVICE: Integra® Miltex® (10381780503972)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: PM-855
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PM-855
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780503972
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® DeMayo Two Point Discrimination Device

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?
47165	Two-point aesthesiometer	A manual stimulator designed to determine tactile sensibility by testing a patient's two-point touch discrimination. It is typically a two-branched instrument joined at the top by a pivot (compass-like), with two points that are applied to the skin to test touch discrimination. The device is typically used during physical examinations for detecting peripheral neuropathy and/or in diabetes mellitus or leprosy diagnostics. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWI	Discriminator, two-point

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: c3968905-0e57-44a4-a1b2-e35b94fde2c2
Public Version Date: April 27, 2023
Public Version Number: 2
DI Record Publish Date: October 01, 2020