Primary Device ID | 00815362021675 |
NIH Device Record Key | 48de1c65-053f-4fc9-9896-f9fe3bc85932 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SURE-LOK (TM) |
Version Model Number | 7004PS |
Catalog Number | 43-TL-5535 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815362021675 [Primary] |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
[00815362021675]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-24 |
00815362021880 | Triple Lead Screw 5.5mmx45mm (qty. 25) |
00815362021842 | Triple Lead Screw 6.5mmx40mm (qty. 167) |
00815362021811 | Triple Lead Screw 5.5mmx40mm (qty. 74) |
00815362021798 | Triple Lead Screw 6.5mmx45mm (qty. 50) |
00815362021774 | Triple Lead Screw 5.5mmx50mm (qty. 79) |
00815362021767 | Triple Lead Screw 5.5mmx45mm (qty. 25) |
00815362021750 | Triple Lead Screw 5.5mmx45mm (qty. 15) |
00815362021712 | TRIPLE LEAD SCREW 5.5MMx45mm (QTY: 23) |
00815362021699 | TRIPLE LEAD SCREW 5.5mmx40mm (qty. 26) |
00815362021682 | Triple Lead Screw 55mmX40mm (qty. 27) |
00815362021675 | Triple Lead Screw 5.5mmx35mm (qty. 20) |
00815362021668 | Triple Lead Screw 6.5mmx40mm (qty. 45) |
00815362021644 | TRIPLE LEAD SCREW 6.5mmx45 (qty. 83) |