| Primary Device ID | M248CRWBP1 |
| NIH Device Record Key | cdb77ab8-fb1d-4082-b9fa-7ae2f5d3f7d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CRW™ |
| Version Model Number | CRWBP |
| Company DUNS | 963856096 |
| Company Name | INTEGRA LIFESCIENCES CORPORATION |
| 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 | true |
| 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)654-2873 |
| custsvcnj@integralife.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780252603 [Primary] |
| HIBCC | M248CRWBP1 [Secondary] |
| HAW | Neurological stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-16 |
| Device Publish Date | 2016-07-26 |
| M268WRISTFUSESET0 - Integra® Total Wrist Fusion System | 2024-04-05 The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nin |
| M248437A2224SRL1 - MAYFIELD® | 2024-04-05 MAYFIELD® XR2 Extension Arm Assembly |
| M2483138R1 - Omni-Tract® | 2024-04-05 Deaver Fixed Retractor, 2.75in x 4.5in (7.0cm x 11.4cm) |
| M2483086P1 - Omni-Tract® | 2024-04-05 Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75° |
| M2483145P1 - Omni-Tract® | 2024-04-05 Kelly Mod Retractor, 3in x 3in (7.6cm x 7.6cm) Fixed |
| M2483223P1 - Omni-Tract® | 2024-04-05 Fence Swivel Blade with 3/8in (1.0cm) Hole, 4in x 5in (10.2cm x 12.7cm) |
| M268S438A1200B1 - BUDDE® | 2024-04-05 SAMY™ Vascular Retractor Blade – Long 4.6" |
| M268S443A1012A1 - BUDDE® | 2024-04-05 BUDDE® Halo 12 inch (300 mm) Flex Arm |