Primary Device ID | 07640151095048 |
NIH Device Record Key | 0a30e403-ddce-4ee7-8088-f34333418d86 |
Commercial Distribution Discontinuation | 2019-02-05 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | ROMEO 2 PAD INSTRUMENTATION |
Version Model Number | PAD-IN 12 00-N |
Catalog Number | PAD-IN 12 00-N |
Company DUNS | 483016148 |
Company Name | SpineArt SA |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640151095048 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07640151095048]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-02-06 |
Device Publish Date | 2018-07-31 |
07640178975040 | Spinous process compression forceps |
07640178973756 | Compression forceps |
07640178972155 | Multiaxial Plate Inserter |
07640178972148 | Locking Plate Inserter |
07640151095048 | Spinous process compression forceps |
07640151092153 | Multiaxial Plate Inserter |
07640151092146 | Locking Plate Inserter |
07640151081874 | Trial Implant Size 18 |
07640151081867 | Trial Implant Size 16 |
07640139349323 | Revision screwdriver |
07640139349309 | Compactor |
07640139349293 | Compaction Base |
07640139349286 | Implant Holder |
07640139349279 | Trial Implant Size 14 |
07640139349262 | Trial Implant Size 12 |
07640139349255 | Trial Implant Size 10 |
07640139349248 | Trial Implant Size 08 |
07640178989269 | EMPTY INSTRUMENTS TRAY |