| Primary Device ID | 00815482020060 |
| NIH Device Record Key | fc438fe6-0867-4047-987b-b515398fe439 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CRP™ Cuff Repair Plate System |
| Version Model Number | 45-IM-AB030 |
| Catalog Number | 45-IM-AB030 |
| 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 |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815482020060 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00815482020060]
Moist Heat or Steam Sterilization
[00815482020060]
Moist Heat or Steam Sterilization
[00815482020060]
Moist Heat or Steam Sterilization
[00815482020060]
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 |