| Primary Device ID | 00191083046921 |
| NIH Device Record Key | 2d9d2fa6-e302-4e8e-aa2e-bc9179751dfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision Allograft Cartilage Kit (PACK™) |
| Version Model Number | PAC-A1722 |
| Catalog Number | PAC-A1722 |
| Company DUNS | 117560455 |
| Company Name | Rti Surgical, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083046921 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
[00191083046921]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-22 |
| Device Publish Date | 2024-10-14 |
| 00191083047263 | PACK 2.0 Tray Bravo |
| 00191083047256 | PACK 2.0 Tray Alpha |
| 00191083047249 | PACK Coring Drill, 34mm |
| 00191083047232 | PACK Coring Drill, 32mm |
| 00191083047225 | PACK Coring Drill, 30mm |
| 00191083047218 | PACK Coring Drill, 28mm |
| 00191083047201 | PACK Coring Drill, 26mm |
| 00191083047195 | PACK Coring Drill, 24mm |
| 00191083047188 | PACK Coring Drill, 22mm |
| 00191083047171 | PACK Coring Drill, 20mm |
| 00191083047164 | PACK Coring Drill, 18mm |
| 00191083047157 | PACK Coring Drill, 16mm |
| 00191083047140 | PACK Coring Drill, 14mm |
| 00191083047133 | PACK Coring Drill, 12mm |
| 00191083047126 | PACK Steinmann Pin, Short |
| 00191083047119 | PACK Vise |
| 00191083047102 | PACK Ring Guide, 34mm |
| 00191083047096 | PACK Ring Guide, 32mm |
| 00191083047089 | PACK Ring Guide, 30mm |
| 00191083047072 | PACK Ring Guide, 28mm |
| 00191083047065 | PACK Ring Guide, 26mm |
| 00191083047058 | PACK Ring Guide, 24mm |
| 00191083047041 | PACK Ring Guide, 22mm |
| 00191083047034 | PACK Ring Guide, 20mm |
| 00191083047027 | PACK Ring Guide, 18mm |
| 00191083047010 | PACK Ring Guide, 16mm |
| 00191083047003 | PACK Ring Guide, 14mm |
| 00191083046990 | PACK Ring Guide, 12mm |
| 00191083046983 | PACK, Cap, Core Drill, 34mm |
| 00191083046976 | PACK, Cap, Core Drill, 32mm |
| 00191083046969 | PACK, Cap, Core Drill, 30mm |
| 00191083046952 | PACK, Cap, Core Drill, 28mm |
| 00191083046945 | PACK, Cap, Core Drill, 26mm |
| 00191083046938 | PACK, Cap, Core Drill, 24mm |
| 00191083046921 | PACK, Cap, Core Drill, 22mm |
| 00191083046914 | PACK, Cap, Core Drill, 20mm |
| 00191083046907 | PACK, Cap, Core Drill, 18mm |
| 00191083046891 | PACK, Cap, Core Drill, 16mm |
| 00191083046884 | PACK, Cap, Core Drill, 14mm |
| 00191083046877 | PACK, Cap, Core Drill, 12mm |
| 00191083046860 | Ruler |
| 00191083046853 | Steinmann Pin |
| 00191083046846 | PACK TAMP, 32MM |
| 00191083046839 | PACK TAMP, 28MM |
| 00191083046822 | PACK TAMP, 24MM |
| 00191083046815 | PACK TAMP, 20MM |
| 00191083046808 | PACK TAMP, 16MM |
| 00191083046792 | PACK TAMP, 12MM |
| 00191083046785 | SAW JIG, PACK |
| 00191083046778 | Coupling, PACK |