| Primary Device ID | 00190776028404 | 
| NIH Device Record Key | 240040af-2cf2-4517-a7cf-27fceb48caed | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Depuy | 
| Version Model Number | 03.028.095 | 
| 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 | false | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00190776028404 [Primary] | 
| HTO | Reamer | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
Moist Heat or Steam Sterilization
[00190776028404]
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 | 2017-11-03 | 
| 00190776121204 | Graphic Case / Tissue and Palatal Retractor Instruments | 
| 00190776121198 | Palatal Retractor Frame Blade Long | 
| 00190776121181 | Palatal Retractor Frame Blade Medium | 
| 00190776121174 | Palatal Retractor Frame Blade Short | 
| 00190776121167 | Palatal Retractor Frame | 
| 00190776028442 | Lid - Monobloc Flexible Reamer Case | 
| 00190776028435 | Base - Monobloc Flexible Reamer Case | 
| 00190776028428 | Monobloc Flexible Reamer, 10.5mm, 385mm | 
| 00190776028411 | Monobloc Flexible Reamer, 10.0mm, 385mm | 
| 00190776028404 | Monobloc Flexible Reamer, 9.5mm, 385mm | 
| 00190776028398 | Monobloc Flexible Reamer, 9.0mm, 385mm | 
| 00190776028381 | Monobloc Flexible Reamer, 8.5mm, 385mm | 
| 00190776028374 | Monobloc Flexible Reamer, 8.0mm, 385mm | 
| 00190776028367 | Monobloc Flexible Reamer, 7.5mm, 385mm | 
| 00190776028350 | Monobloc Flexible Reamer, 7.0mm, 385mm | 
| 00190776028343 | Monobloc Flexible Reamer, 6.5mm, 385mm | 
| 00190776028336 | Monobloc Flexible Reamer, 6.0mm, 385mm | 
| 00190776028329 | Mallet, Small | 
| 00190776028312 | Caliper, Castroviejo Style, 0 mm-40 mm | 
| 00190776028305 | Scalpel Handle, Round | 
| 00190776028299 | Osteotome, Epker Style, 4mm | 
| 00190776028282 | Needle Holder, Necked, Long | 
| 00190776028275 | Needle Holder, Crile-Wood Style, Medium | 
| 00190776028268 | Needle Holder, Crile-Wood Style, Short, Smooth | 
| 00190776028251 | Scissors, Iris Style, Curved | 
| 00190776028244 | Scissors, Flat Pointed, Curved | 
| 00190776028237 | Scissors, Gorney Style, Long, Curved | 
| 00190776028213 | Scissors, Kelly Style | 
| 00190776028206 | Tissue Forceps, Adson Brown Style | 
| 00190776028190 | Tissue Forceps, Adson Style | 
| 00190776028183 | Long Tissue Forceps, DeBakey Style | 
| 00190776028176 | Double Ended Periosteal Elevator, Angle, 19 cm | 
| 00190776028169 | Double Ended Periosteal Elevator, Straight, 19cm | 
| 00190776028152 | Double Hook Skin Retractor, 2mm | 
| 00190776028145 | Single Hook Skin Retractor, 3mm | 
| 00190776028138 | Double Ended Retractor | 
| 00190776155407 | TRAY F/DINGO/DBL BEND INSTR | 
| 00190776155391 | TRAY F/STRAIGHT/SGL BEND INSTR | 
| 00190776155384 | TRAY FOR RONGEURS | 
| 00190776152918 | LAT 6MM ANGLED SPREADER | 
| 00190776152901 | LAT 8MM ANGLED RING CURETTE, FLAT | 
| 00190776152895 | LAT 8MM ANGLED RING CURETTE | 
| 00190776152888 | LAT 6MM DOWN-BITING ATP CURETTE | 
| 00190776152871 | LAT 4MM DOWN-BITING ATP CURETTE | 
| 00190776152864 | LAT 6MM ANGLED DOWN-BITING CURETTE, LEFT | 
| 00190776152857 | LAT 6MM ANGLED DOWN-BITING CURETTE, RIGHT | 
| 00190776152840 | LAT 4MM ANGLED DOWN-BITING CURETTE, LEFT | 
| 00190776152833 | LAT 4MM ANGLED DOWN-BITING CURETTE, RIGHT | 
| 00190776152826 | LAT 6MM UP-BITING ATP CURETTE | 
| 00190776152819 | LAT 4MM UP-BITING ATP CURETTE | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  DEPUY  73241313  1166357 Live/Registered | Boehringer Mannheim Corporation 1979-12-03 | 
|  DEPUY  72300912  0893803 Live/Registered | DEPUY MANUFACTURING CO., INC. 1968-06-20 |