Primary Device ID | 00643169703568 |
NIH Device Record Key | 49640921-ed3d-4cf5-a87b-dde655fc9c6b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Balloon Kyphoplasty Essentials Kit |
Version Model Number | NH153PB-CDS |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
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 | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169703568 [Primary] |
HRX | ARTHROSCOPE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-02-25 |
00643169703599 | KIT NH152PB-CDS 15/2 SPINE ESSEN FF CDS |
00643169703582 | KIT NH102PB-CDS 10/2 SPINE ESSEN FF CDS |
00643169703575 | KIT NH203PB-CDS 20/3 SPINE ESSEN FF CDS |
00643169703568 | KIT NH153PB-CDS 15/3 SPINE ESSEN FF CDS |
00643169703551 | KIT NH103PB-CDS 10/3 SPINE ESSEN FF CDS |
00643169703544 | KIT NH152PB 15/2 SPINE ESSEN FF |
00643169703537 | KIT NH102PB 10/2 SPINE ESSEN FF |
00643169703520 | KIT NH203PB 20/3 SPINE ESSEN FF |
00643169703513 | KIT NH153PB 15/3 SPINE ESSEN FF |
00643169703506 | KIT NH103PB 10/3 SPINE ESSEN FF |