Primary Device ID | 00840097505305 |
NIH Device Record Key | 54422814-a694-4967-ae65-30401ca02aae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | restor3d Lumbar Instrumentation |
Version Model Number | 5113-B2002 |
Company DUNS | 080819836 |
Company Name | Restor3d, 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 | false |
Device Combination Product | false |
Single Use | false |
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 | 00840097505305 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
[00840097505305]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-25 |
Device Publish Date | 2024-04-17 |
00840097509990 | ALIF Disc Prep - Level 3 |
00840097509983 | ALIF Disc Prep - Level 2 |
00840097509976 | ALIF Disc Prep - Level 1 |
00840097509969 | ALIF Disc Prep - Lid |
00840097509952 | ALIF Disc Prep - Case |
00840097509730 | Large Cobb Angled 28mm |
00840097509723 | Small Cobb Angled 22mm |
00840097509716 | Large Cobb Straight 28mm |
00840097509709 | Small Cobb Straight 22mm |
00840097509693 | Osteotome Angled 15mm |
00840097509686 | Osteotome Straight 15mm |
00840097509679 | Nerve Root Probe |
00840097509662 | Nerve Hook |
00840097509655 | Push Curette (Elephant foot) |
00840097509648 | Ring Curette Stirrup Up |
00840097509631 | Ring Curette Stirrup Straight |
00840097509624 | Cup 5 Curette Up |
00840097509617 | Cup 2 Curette Up |
00840097509600 | Cup 5 Curette Straight |
00840097509594 | Cup 2 Curette Straight |
00840097509587 | Rasp Angled Double Sided |
00840097509570 | Rasp Straight Double Sided |
00840097509563 | Bone Rongeur 8mm Double Action |
00840097509556 | Kerrison Rongeur Straight 6mm, 13" |
00840097509549 | Kerrison Rongeur Straight 4mm, 13" |
00840097509532 | Kerrison Rongeur Straight 2mm, 13" |
00840097505305 | Pituitary Rongeur Straight 6mm, 13" |
00840097505299 | Pituitary Rongeur Straight 4mm, 13" |
00840097505282 | Scalpel Handle Long 15" |