| Primary Device ID | 00885554014112 |
| NIH Device Record Key | 7cae1cae-d429-4f53-9da8-7fa3a499be89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIORAPTOR / ULTRABRAID |
| Version Model Number | 72200690 |
| Catalog Number | 72200690 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885554014112 [Primary] |
| GS1 | 20885554014116 [Package] Package: BX [3 Units] In Commercial Distribution |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2015-09-28 |
| 00885554014112 | BIORAPTOR 2.9 STR ANCHOR PCK 2 ULTRBRD |
| 00885554013573 | BIORAPTOR 2.9 SUTURE ANCHOR PACK 1 ULTBR |
| 03596010656469 | BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE |
| 03596010656452 | BIORAPTOR CRV 2.3 PK SA UB COBRD BLACK |
| 03596010595096 | BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB WTE |
| 03596010595089 | BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB BLK |
| 03596010595072 | BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB |
| 03596010607553 | BIRAPTR 2.9 AB SUTURE ANCR TWO 38 U/B |