Primary Device ID | 00643169671706 |
NIH Device Record Key | c40b2aad-ecdc-4638-9c25-2c193571fb78 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KyphPak® First Fracture Tray |
Version Model Number | KPX103AB-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 (at max 25°C/77°F) |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (at max 25°C/77°F) |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169671706 [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 | 2016-04-03 |
00643169671843 | KIT KPX203PB-CDS 20/3 FF 1-STEP WITH CDS |
00643169671829 | KIT KPX203AB-CDS 20/3 FF ADV WITH CDS |
00643169671805 | KIT KPX203RB-CDS 20/3 FF OTEO WITH CDS |
00643169671782 | KIT KPX153PB-CDS 15/3 FF 1-STEP WITH CDS |
00643169671768 | KIT KPX153AB-CDS 15/3 FF ADV WITH CDS |
00643169671744 | KIT KPX153RB-CDS 15/3 FF OSTEO WITH CDS |
00643169671720 | KIT KPX103PB-CDS 10/3 FF 1-STEP WITH CDS |
00643169671706 | KIT KPX103AB-CDS 10/3 FF ADV WITH CDS |
00643169671683 | KIT KPX103RB-CDS 10/3 FF OSTEO WITH CDS |
00643169671669 | KIT KEX202EB-CDS- 20/2 FF WITH CDS |
00643169671645 | KIT KEX152EB-CDS- 15/2 FF WITH CDS |
00643169671621 | KIT KEX102EB-CDS- 10/2 FF WITH CDS |