Primary Device ID | 00190776385910 |
NIH Device Record Key | 6e9d62ae-0968-48d9-804d-b3e0ab51da47 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DePuy Synthes |
Version Model Number | 431110135 |
Company DUNS | 792528510 |
Company Name | Avalign Technologies, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190776385910 [Primary] |
OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-11 |
Device Publish Date | 2025-08-01 |
00190776153205 | 11.5mm Monobloc Flexible Reamer - Long |
00190776153175 | 10mm Monobloc Flexible Reamer - Long |
00190776157715 | Advanced Reaming System - Standard Outer Lid |
00190776157708 | Advanced Reaming System - Standard Outer Base |
00190776157692 | Advanced Reaming System - Long Outlier - Base |
00190776157685 | Advanced Reaming System - Standard Outlier - Base |
00190776153373 | Advanced Reaming System - Long - Lid |
00190776153366 | Advanced Reaming System - Long Efficiency - Base |
00190776153359 | Advanced Reaming System - Standard - Lid |
00190776153342 | Advanced Reaming System - Standard Efficiency - Base |
00190776153335 | 18mm Monobloc Flexible Reamer - Long |
00190776153328 | 17.5mm Monobloc Flexible Reamer - Long |
00190776153311 | 17mm Monobloc Flexible Reamer - Long |
00190776153304 | 16.5mm Monobloc Flexible Reamer - Long |
00190776153298 | 16mm Monobloc Flexible Reamer - Long |
00190776153281 | 15.5mm Monobloc Flexible Reamer - Long |
00190776153274 | 15mm Monobloc Flexible Reamer - Long |
00190776153267 | 14.5mm Monobloc Flexible Reamer - Long |
00190776153250 | 14mm Monobloc Flexible Reamer - Long |
00190776153243 | 13.5mm Monobloc Flexible Reamer - Long |
00190776153236 | 13mm Monobloc Flexible Reamer - Long |
00190776153229 | 12.5mm Monobloc Flexible Reamer - Long |
00190776153212 | 12mm Monobloc Flexible Reamer - Long |
00190776153199 | 11mm Monobloc Flexible Reamer - Long |
00190776153182 | 10.5mm Monobloc Flexible Reamer - Long |
00190776153168 | 9.5mm Monobloc Flexible Reamer - Long |
00190776153151 | 9mm Monobloc Flexible Reamer - Long |
00190776153144 | 8.5mm Monobloc Flexible Reamer - Long |
00190776153137 | 8mm Monobloc Flexible Reamer - Long |
00190776153120 | 18mm Monobloc Flexible Reamer - Standard |
00190776153113 | 17.5mm Monobloc Flexible Reamer - Standard |
00190776153106 | 17mm Monobloc Flexible Reamer - Standard |
00190776153090 | 16.5mm Monobloc Flexible Reamer - Standard |
00190776153083 | 16mm Monobloc Flexible Reamer - Standard |
00190776153076 | 15.5mm Monobloc Flexible Reamer - Standard |
00190776153069 | 15mm Monobloc Flexible Reamer - Standard |
00190776153052 | 14.5mm Monobloc Flexible Reamer - Standard |
00190776153045 | 14mm Monobloc Flexible Reamer - Standard |
00190776153038 | 13.5mm Monobloc Flexible Reamer - Standard |
00190776153021 | 13mm Monobloc Flexible Reamer - Standard |
00190776153014 | 12.5mm Monobloc Flexible Reamer - Standard |
00190776153007 | 12mm Monobloc Flexible Reamer - Standard |
00190776152994 | 11.5mm Monobloc Flexible Reamer - Standard |
00190776152987 | 11mm Monobloc Flexible Reamer - Standard |
00190776152970 | 10.5mm Monobloc Flexible Reamer - Standard |
00190776152963 | 10mm Monobloc Flexible Reamer - Standard |
00190776152956 | 9.5mm Monobloc Flexible Reamer - Standard |
00190776152949 | 9mm Monobloc Flexible Reamer - Standard |
00190776152932 | 8.5mm Monobloc Flexible Reamer - Standard |
00190776152925 | 8mm Monobloc Flexible Reamer - Standard |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DEPUY SYNTHES 86030065 4969115 Live/Registered |
DePuy Synthes, Inc. 2013-08-06 |