| Primary Device ID | M68955110010 |
| NIH Device Record Key | 0166f11a-0858-48d8-9de4-b4b3dbd9fb6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO PELVIC SPLINT |
| Version Model Number | 01 |
| Catalog Number | 55-110 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedicalsystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68955110010 [Primary] |
| HSQ | Belt, Pelvic, Traction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-04-12 |
| Device Publish Date | 2018-05-25 |
| M68955110010 | PRO PELVIC SPLINT 1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle Intended for |
| M68955110020 | PRO PELVIC SPLINT 1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle Intended for |