| Primary Device ID | 10841736113353 |
| NIH Device Record Key | bdf70ae4-7cab-4aed-9ed4-514334c343c1 |
| Commercial Distribution Discontinuation | 2026-01-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BODY RESTRAINT |
| Version Model Number | 6-010-54 |
| Company DUNS | 078375583 |
| Company Name | SKYTRON LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841736113353 [Primary] |
| LWG | Surgical Table Cushion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-03 |
| Device Publish Date | 2019-03-15 |
| 10841736113353 | BODY RESTRAINT 2" WIDE 108" LONG SINGLE STRAP ONE BUCKLE |
| 10841736113346 | BODY RESTRAINT 72" X 2" WIDE VELCRO FASTENER NONCONDUCTIVE |