Shoulder Brace

GUDID 16974500613590

Resuable and Adjustable Shoulder Brace Materials: Nylon,Neoprene Size: One Size,fits left and right shoulder

GCMEDICA ENTERPRISE LTD.(WUXI)

Shoulder immobilizer/orthosis, reusable
Primary Device ID16974500613590
NIH Device Record Key4a8a1f44-77a5-469b-b836-024c529a6984
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Brace
Version Model NumberJP07A01
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
GS106974500613593 [Primary]
GS116974500613590 [Package]
Contains: 06974500613593
Package: [6 Units]
In Commercial Distribution

FDA Product Code

IOYSupport, Arm

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

Devices Manufactured by GCMEDICA ENTERPRISE LTD.(WUXI)

16974500613552 - Elbow Support2025-12-22 Resuable and Adjustable Elbow Support Matrials: Nylon, Neoprene Size: One Size,fits left and right Elbow
16974500613569 - Compression Gloves2025-12-22 Resuable and Adjustable Compression Gloves Materials: Copper fibers, Spandex Size: L,XL
16974500613576 - Knee Brace2025-12-22 Adjustable Knee Brace Materials: Nylon, Neoprene Size: One Size,fits left and right Knee
16974500613583 - Knee brace2025-12-22 Adjustable Knee Brace Materials: Polyester, Rubber fibers Size: L/XL,fits left and right Knee
16974500613590 - Shoulder Brace2025-12-22Resuable and Adjustable Shoulder Brace Materials: Nylon,Neoprene Size: One Size,fits left and right shoulder
16974500613590 - Shoulder Brace2025-12-22 Resuable and Adjustable Shoulder Brace Materials: Nylon,Neoprene Size: One Size,fits left and right shoulder
16974500613606 - Cervical Collar2025-12-22 Reusable and Adjustable Cervical Collar Materials:Nylon ,Sponge Size:One Size
16974500613613 - Arm Sling2025-12-22 Reusable and Adjustable Arm Sling Materials: Polyester,Sponge Size: One Size,fits left and right arm
16974500613620 - Arm Sling2025-12-22 Reusable and Adjustable Arm Sling Materials: Polyester, Nylon Size: One Size,fits left and right arm

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