| Primary Device ID | 16974500613460 |
| NIH Device Record Key | 0a63a396-63ac-40fc-9f4b-0d5af000691c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wrist Support |
| Version Model Number | JP01D01 |
| Company DUNS | 560122957 |
| Company Name | GCMEDICA ENTERPRISE LTD.(WUXI) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974500613463 [Primary] |
| GS1 | 16974500613460 [Package] Contains: 06974500613463 Package: [12 Units] In Commercial Distribution |
| ILH | Splint, Hand, And Components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-16 |
| Device Publish Date | 2025-12-08 |
| 16974500613552 - Elbow Support | 2025-12-22 Resuable and Adjustable Elbow Support Matrials: Nylon, Neoprene Size: One Size,fits left and right Elbow |
| 16974500613569 - Compression Gloves | 2025-12-22 Resuable and Adjustable Compression Gloves Materials: Copper fibers, Spandex Size: L,XL |
| 16974500613576 - Knee Brace | 2025-12-22 Adjustable Knee Brace Materials: Nylon, Neoprene Size: One Size,fits left and right Knee |
| 16974500613583 - Knee brace | 2025-12-22 Adjustable Knee Brace Materials: Polyester, Rubber fibers Size: L/XL,fits left and right Knee |
| 16974500613590 - Shoulder Brace | 2025-12-22 Resuable and Adjustable Shoulder Brace Materials: Nylon,Neoprene Size: One Size,fits left and right shoulder |
| 16974500613606 - Cervical Collar | 2025-12-22 Reusable and Adjustable Cervical Collar Materials:Nylon ,Sponge Size:One Size |
| 16974500613613 - Arm Sling | 2025-12-22 Reusable and Adjustable Arm Sling Materials: Polyester,Sponge Size: One Size,fits left and right arm |
| 16974500613620 - Arm Sling | 2025-12-22 Reusable and Adjustable Arm Sling Materials: Polyester, Nylon Size: One Size,fits left and right arm |