Primary Device ID | 10888857556218 |
NIH Device Record Key | c203f304-061a-4a5b-834d-9681bb728d73 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ATP Disc Prep |
Version Model Number | 8030-90049 |
Catalog Number | 8030-90049 |
Company DUNS | 146060863 |
Company Name | K2M, INC. |
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 | 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(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com | |
Phone | +1(571)919-2000 |
mark.zellers@stryker.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10888857556218 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
[10888857556218]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-28 |
Device Publish Date | 2024-03-20 |
10888857562905 | Instrument Tray |
10888857562899 | Instrument Tray |
10888857562882 | Instrument Tray |
10888857562875 | Instrument Tray |
10888857562868 | Instrument Tray |
10888857562851 | Instrument Tray |
10888857562844 | Instrument Tray |
10888857556355 | Orientation Indicator |
10888857556348 | Cobb, Left ATP, 50x22 mm |
10888857556331 | Cobb, Left ATP, 50x18 mm |
10888857556256 | Disc Wedge ATP, 4-6 mm |
10888857556249 | Disc Wedge ATP, 3-5 mm |
10888857556201 | Reverse Angled Curette ATP, #4 |
10888857556195 | Reverse Angled Curette ATP, #2 |
10888857556188 | Forward Angled Curette ATP, #4 |
10888857556171 | Forward Angled Curette ATP, #2 |
10888857556164 | Stirrup Push/Pull Curette ATP |
10888857556157 | One Sided Rasp, Right ATP |
10888857556140 | One Sided Rasp, Left ATP |
10888857556133 | Cobb, Right ATP, 60x22mm |
10888857556126 | Cobb, Right ATP, 60x18mm |
10888857556119 | Cobb, Left ATP, 60x22 mm |
10888857556102 | Cobb, Left ATP, 60x18 mm |
10888857556096 | Cobb, Right ATP, 50x22mm |
10888857556089 | Cobb, Right ATP, 50x18mm |
10888857556232 | Box Chisel ATP, 10mm |
10888857556225 | Box Chisel ATP, 8mm |
10888857556218 | Box Chisel ATP, 6mm |
10888857562042 | Pituitary ATP, 5mm |
10888857562035 | Pituitary ATP, 3mm |