Primary Device ID | 00714646001504 |
NIH Device Record Key | 9960ebb7-56c6-4610-a2c0-cbd8271668d9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pelvis Belly Replacement Face Cushion Assembly |
Version Model Number | PPRT-5107 |
Catalog Number | PPRT-5107 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | true |
Serial Number | false |
Manufacturing Date | true |
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 | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00714646001504 [Primary] |
IYE | Accelerator, linear, medical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-29 |
Device Publish Date | 2025-08-21 |
00714646001474 - Pelvis Belly Replacement Leg Cushion | 2025-08-29 Pelvis Belly Replacement Leg Cushion |
00714646001481 - Pelvis Belly Replacement Arm Rest Cushion | 2025-08-29 Pelvis Belly Replacement Arm Rest Cushion |
00714646001498 - Pelvis Belly Replacement Stomach Cushion - Medium | 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Medium |
00714646001504 - Pelvis Belly Replacement Face Cushion Assembly | 2025-08-29Pelvis Belly Replacement Face Cushion Assembly |
00714646001504 - Pelvis Belly Replacement Face Cushion Assembly | 2025-08-29 Pelvis Belly Replacement Face Cushion Assembly |
00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small | 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Small |
10714646001099 - Microsuction Stater Pack | 2025-07-16 Microsuction Starter Pack |
10714646001105 - Microsuction Replacement Pack | 2025-07-16 Microsuction Replacement Pack |
10714646001129 - Sample: Opti-Tatt | 2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border |