Primary Device ID | 00815948022416 |
NIH Device Record Key | 697a1ab4-eec8-4d7f-a51f-ee7599ef8cd4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | REAL System Bands |
Version Model Number | BND-A |
Company DUNS | 191077671 |
Company Name | PENUMBRA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815948022416 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-06-08 |
Device Publish Date | 2020-06-17 |
00815948024779 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 3 cm |
00815948024793 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 4 cm |
00815948029460 - REAL y-Series | 2024-04-24 REAL y-Series 2 |
00815948029477 - REAL y-Series | 2024-04-24 REAL y-Series 2 Eval |
00815948029484 - REAL y-Series | 2024-04-24 REAL y-Series GO |
00815948029507 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 5 cm |
00815948029514 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 6 cm |
00815948029521 - Swift Coil System | 2024-04-24 SwiftPAC Coil, 7 cm |