| Primary Device ID | 00190776153298 |
| NIH Device Record Key | d4754eb0-f3d3-4d12-925c-472861f38b38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Depuy Synthes |
| Version Model Number | 03.045.360 |
| Company DUNS | 792528510 |
| Company Name | AVALIGN TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com | |
| Phone | +1-877-289-1096 |
| Product.questions@avalign.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190776153298 [Primary] |
| HTO | Reamer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
[00190776153298]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-13 |
| Device Publish Date | 2020-10-05 |
| 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 |