Cervical Collar

GUDID 16974500613606

Reusable and Adjustable Cervical Collar Materials:Nylon ,Sponge Size:One Size

GCMEDICA ENTERPRISE LTD.(WUXI)

Cervical spine collar, reusable
Primary Device ID16974500613606
NIH Device Record Keycb73678e-9931-4f86-9482-649166305cd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervical Collar
Version Model NumberJP08A01
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
GS106974500613609 [Primary]
GS116974500613606 [Package]
Contains: 06974500613609
Package: [8 Units]
In Commercial Distribution

FDA Product Code

IQKOrthosis, Cervical

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 Brace2025-12-22 Resuable and Adjustable Shoulder Brace Materials: Nylon,Neoprene Size: One Size,fits left and right shoulder
16974500613606 - Cervical Collar2025-12-22Reusable and Adjustable Cervical Collar Materials:Nylon ,Sponge Size:One Size
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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