Gripper 3 Knee, 12" Coolflex

GUDID 00802357172375

MEDICAL SPECIALTIES INCORPORATED

Knee support orthosis
Primary Device ID00802357172375
NIH Device Record Key0f79bacd-d357-4592-b2e1-a1f007f4f204
Commercial Distribution StatusIn Commercial Distribution
Brand NameGripper 3 Knee, 12" Coolflex
Version Model Number117237
Company DUNS003173028
Company NameMEDICAL SPECIALTIES INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802357172375 [Primary]

FDA Product Code

ITQJoint, Knee, External Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-22
Device Publish Date2025-01-14

On-Brand Devices [Gripper 3 Knee, 12" Coolflex]

00802357172399117239
00802357172382117238
00802357172375117237
00802357172368117236
00802357172351117235
00802357172344117234
00802357172320117232
00802357172313117231

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.