Primary Device ID | 00815482020138 |
NIH Device Record Key | b48df63e-fed8-4117-8261-5f74367963b4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CRP™ Cuff Repair Plate System |
Version Model Number | 16-IN-KW150 |
Catalog Number | 16-IN-KW150 |
Company DUNS | 053545528 |
Company Name | Shoulder Options, 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 | true |
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 |
Phone | 704-512-0000 |
burgan@shoulderoptions.com | |
Phone | 704-512-0000 |
burgan@shoulderoptions.com | |
Phone | 704-512-0000 |
burgan@shoulderoptions.com | |
Phone | 704-512-0000 |
burgan@shoulderoptions.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815482020138 [Primary] |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815482020138]
Moist Heat or Steam Sterilization
[00815482020138]
Moist Heat or Steam Sterilization
[00815482020138]
Moist Heat or Steam Sterilization
[00815482020138]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-11-02 |
00815482020213 | 4.5mm QC/AO Handle |
00815482020206 | Crochet Hook |
00815482020190 | Penetrating Awl |
00815482020183 | 2.5mm Small Hex Screwdriver with Spring Tip |
00815482020176 | CRP Guide's Guide Handle |
00815482020169 | Depth Gauge |
00815482020152 | 4.5mm Threaded Drill Guide |
00815482020145 | 4.5mm Drill Bit |
00815482020138 | 1.6 x 150mm K-Wire, trocar tip |
00815482020121 | CRP Guide's Guide, Left |
00815482020114 | CRP Guide's Guide, Right |
00815482020107 | Anchor Bolt, 10mm |
00815482020091 | Anchor Bolt, 15mm |
00815482020084 | Anchor Bolt, 20mm |
00815482020077 | Anchor Bolt, 25mm |
00815482020060 | Anchor Bolt, 30mm |
00815482020053 | Anchor Bolt, 35mm |
00815482020046 | Anchor Bolt, 40mm |
00815482020039 | Anchor Bolt, 45mm |
00815482020022 | Anchor Bolt, 50mm |
00815482020015 | CRP Plate, Left |
00815482020008 | CRP Plate, Right |