Knee brace

GUDID 16974500613583

Adjustable Knee Brace Materials: Polyester, Rubber fibers Size: L/XL,fits left and right Knee

GCMEDICA ENTERPRISE LTD.(WUXI)

Knee support orthosis
Primary Device ID16974500613583
NIH Device Record Key771a1855-0454-44c3-9b2f-e20d95e3d6b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnee brace
Version Model NumberJP04C02
Company DUNS560122957
Company NameGCMEDICA ENTERPRISE LTD.(WUXI)
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106974500613586 [Primary]
GS116974500613583 [Package]
Contains: 06974500613586
Package: [12 Units]
In Commercial Distribution

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 Date2025-12-22
Device Publish Date2025-12-12

On-Brand Devices [Knee brace]

16974500613583Adjustable Knee Brace Materials: Polyester, Rubber fibers Size: L/XL,fits left and right Knee
16974500613576Adjustable Knee Brace Materials: Nylon, Neoprene Size: One Size,fits left and right Knee

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