Primary Device ID | 00840097503127 |
NIH Device Record Key | 3935a102-ecc9-49ac-927c-11bb5103abeb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | restor3d Disposable Instrument, Wedge Trial |
Version Model Number | 6100-NSP-A0506 |
Company DUNS | 080819836 |
Company Name | Restor3d |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840097503127 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
[00840097503127]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-23 |
Device Publish Date | 2021-11-15 |
00840097502571 | Disposable Trial, Cotton Wedge 001, Medium Footprint, 6mm Thickness |
00840097502564 | Disposable Trial Cotton Wedge 001, Medium Footprint,5mm Thickness |
00840097502557 | Disposable Trial, Cotton Wedge 001, Medium Footprint, 4mm Thickness |
00840097502540 | Disposable Trial, Cotton Wedge 001, Small Footprint, 6mm Thickness |
00840097502533 | Disposable Trial, Cotton Wedge 001, Small Footprint, 5mm Thickness |
00840097502526 | Disposable Trial, Cotton Wedge 001, Small Footprint, 4mm Thickness |
00840097501611 | Disposable Trial, Evans Wedge, Large Footprint, 12mm Thickness |
00840097501604 | Disposable Trial, Evans Wedge, Large Footprint, 10mm Thickness |
00840097501598 | Disposable Trial, Evans Wedge, Large Footprint, 8mm Thickness |
00840097501581 | Disposable Trial, Evans Wedge, Medium Footprint, 10mm Thickness |
00840097501574 | Disposable Trial, Evans Wedge, Medium Footprint, 12mm Thickness |
00840097501567 | Disposable Trial, Evans Wedge, Medium Footprint, 8mm Thickness |
00840097501550 | Disposable Trial, Evans Wedge, Small Footprint, 12mm Thickness |
00840097501543 | Disposable Trial, Evans Wedge, Small Footprint, 10mm Thickness |
00840097501536 | Disposable Trial, Evans Wedge, Small Footprint, 8mm Thickness |
00840097501420 | Disposable Trial, Cotton Wedge, Medium Footprint, 4mm Thickness |
00840097501413 | Disposable Trial, Cotton Wedge, Medium Footprint, 5mm Thickness |
00840097501406 | Disposable Trial, Cotton Wedge, Medium Footprint, 4mm Thickness |
00840097501390 | Disposable Trial, Cotton Wedge, Small Footprint, 6mm Thickness |
00840097501383 | Disposable Trial, Cotton Wedge, Small Footprint, 5mm Thickness |
00840097501376 | Disposable Trial, Cotton Wedge, Small Footprint, 4mm Thickness |
00840097502984 | Disposable Trial, Evans Wedge 009, Medium Footprint, 12mm Thickness |
00840097502977 | Disposable Trial, Evans Wedge 009, Large Footprint, 12mm Thickness |
00840097502960 | Disposable Trial, Evans Wedge 009, Large Footprint, 10mm Thickness |
00840097502953 | Disposable Trial, Evans Wedge 009, Large Footprint, 8mm Thickness |
00840097502946 | Disposable Trial, Evans Wedge 009, Medium Footprint, 10mm Thickness |
00840097502939 | Disposable Trial, Evans Wedge 009, Medium Footprint, 8mm Thickness |
00840097502922 | Disposable Trial, Evans Wedge 009, Small Footprint, 12mm Thickness |
00840097502915 | Disposable Trial, Evans Wedge 009, Small Footprint, 10mm Thickness |
00840097502908 | Disposable Trial, Evans Wedge 009, Small Footprint, 8mm Thickness |
00840097502762 | Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 8mm Thickness |
00840097502755 | Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 6mm Thickness |
00840097502748 | Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 5mm Thickness |
00840097502731 | Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 4mm Thickness |
00840097503233 | Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Large Footprint, 10/12mm Thickness |
00840097503226 | Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Large Footprint, 08/10mm Thickness |
00840097503219 | Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Medium Footprint, 10/12mm Thicknes |
00840097503202 | Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Medium Footprint, 8/10mm Thickness |
00840097503196 | Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Small Footprint, 10/12mm Thickness |
00840097503189 | Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Small Footprint, 8/10mm Thickness |
00840097503172 | Non-Sterile Disposable Instrument, Cotton Wedge 002, Double Sided, 9/10mm Thickness |
00840097503165 | Non-Sterile Disposable Instrument, Cotton Wedge 002, Double Sided, 7/8mm Thickness |
00840097503158 | Non-Sterile Disposable Instrument, Cotton Wedge 002, Double Sided, 5/6mm Thickness |
00840097503141 | Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Medium Footprint 5/6mm Thickness |
00840097503134 | Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Medium Footprint, 4/5mm Thickness |
00840097503127 | Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Small Footprint, 5/6mm Thickness |
00840097503110 | Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Small Footprint, 4/5mm Thickness |
00840097504636 | Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 5 Degree |
00840097504629 | Disposable Trial, Subtalar Wedge, Large Footprint, 14 mm thickness, 0 degree |
00840097504612 | Disposable Trial, Subtalar Wedge, Large Footprint, 10 mm thickness, 10 degree |