Baby Gorilla®/Gorilla® Plating System P01-901-1301
GUDID 00889795097491
AVITRAC™ Core, MTP Reamer, Ø13 mm
PARAGON 28, INC.
Bone-resection orthopaedic reamer, reusable| Primary Device ID | 00889795097491 |
| NIH Device Record Key | 9eb93807-5ffe-464b-a6e3-e54541d2e632 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Baby Gorilla®/Gorilla® Plating System |
| Version Model Number | P01-901-1301 |
| Catalog Number | P01-901-1301 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889795097491 [Primary] |
FDA Product Code
| HTO | REAMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
[00889795097491]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-23 |
| Device Publish Date | 2020-12-15 |
On-Brand Devices [Baby Gorilla®/Gorilla® Plating System]
| 00889795100573 | R3CON Non-Locking Screw, Ø4.20 x 58mm |
| 00889795100566 | R3CON Non-Locking Screw, Ø4.20 x 56mm |
| 00889795100559 | R3CON Non-Locking Screw, Ø4.20 x 54mm |
| 00889795100542 | R3CON Non-Locking Screw, Ø4.20 x 52mm |
| 00889795100535 | R3CON Non-Locking Screw, Ø4.20 x 45mm |
| 00889795100528 | R3CON Non-Locking Screw, Ø4.20 x 8mm |
| 00889795100511 | R3CON Locking Screw, Ø4.20 x 58mm |
| 00889795100504 | R3CON Locking Screw, Ø4.20 x 56mm |
| 00889795100498 | R3CON Locking Screw, Ø4.20 x 54mm |
| 00889795100481 | R3CON Locking Screw, Ø4.20 x 52mm |
| 00889795100474 | R3CON Locking Screw, Ø4.20 x 45mm |
| 00889795100467 | R3CON Locking Screw, Ø4.20 x 8mm |
| 00889795100450 | R3CON Non-Locking Screw, Ø3.50 x 58mm |
| 00889795100443 | R3CON Non-Locking Screw, Ø3.50 x 56mm |
| 00889795100436 | R3CON Non-Locking Screw, Ø3.50 x 54mm |
| 00889795100429 | R3CON Non-Locking Screw, Ø3.50 x 52mm |
| 00889795100412 | R3CON Non-Locking Screw, Ø3.50 x 45mm |
| 00889795100405 | R3CON Non-Locking Screw, Ø3.50 x 8mm |
| 00889795100399 | R3CON Locking Screw, Ø3.50 x 70mm |
| 00889795100382 | R3CON Locking Screw, Ø3.50 x 65mm |
| 00889795100375 | R3CON Locking Screw, Ø3.50 x 60mm |
| 00889795100368 | R3CON Locking Screw, Ø3.50 x 58mm |
| 00889795100351 | R3CON Locking Screw, Ø3.50 x 56mm |
| 00889795100344 | R3CON Locking Screw, Ø3.50 x 55mm |
| 00889795100337 | R3CON Locking Screw, Ø3.50 x 54mm |
| 00889795100320 | R3CON Locking Screw, Ø3.50 x 52mm |
| 00889795100313 | R3CON Locking Screw, Ø3.50 x 45mm |
| 00889795100306 | R3CON Locking Screw, Ø3.50 x 8mm |
| 00889795097491 | AVITRAC™ Core, MTP Reamer, Ø13 mm |
| 00889795097484 | AVITRAC™ Core, MTP Reamer, Ø11 mm |
| 00889795097477 | AVITRAC™ Core, MTP Reamer, Ø9 mm |
| 00889795054210 | Precision Guide, Subtalar Joint, Guide Arm, Left |
| 00889795054203 | Precision Guide, Subtalar Joint, Guide Arm, Right |
| 00889795053374 | Over Drill, 5.2 x 120mm, Solid, AO |
| 00889795053367 | Over Drill, 4.5 x 120mm, Solid, AO |
| 00889795053350 | Drill, 3.6 x 160mm, Solid, Measuring, Long, AO |
| 00889795053343 | Drill, 3.1 x 160mm, Solid, Measuring, Long, AO |
| 00889795053336 | Drill, 2.8 x 160mm, Solid, Measuring, Long, AO |
| 00889795053329 | Drill, 2.4 x 160mm, Solid, Measuring, Long, AO |
| 00889795053213 | Lateral TTC Plate, Long, Right |
| 00889795053206 | Lateral TTC Plate, Standard, Right |
| 00889795053183 | Lateral TT Plate, Standard, Right |
| 00889795053169 | Lateral TTC Plate, Long, Left |
| 00889795053152 | Lateral TTC Plate, Standard, Left |
| 00889795053138 | Lateral TT Plate, Standard, Left |
| 00889795053022 | Tap, Double Lead, 5.2mm |
| 00889795053015 | Tap, Double Lead, 4.5mm |
| 00889795052087 | Gorilla, Precision Guide, Straddle, Guide Jig, U-Configuration |
| 00889795051868 | Morselizing Bone Graft Harvester, AO, 10mm |
| 00889795051844 | Morselizing Bone Graft Harvester, AO, 8mm |
Trademark Results [Baby Gorilla]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BABY GORILLA 87482760 5378789 Live/Registered |
PARAGON 28, INC. 2017-06-09 |
 BABY GORILLA 87482750 5378787 Live/Registered |
PARAGON 28, INC. 2017-06-09 |
 BABY GORILLA 85342950 4181983 Dead/Cancelled |
Gorilla, Inc. 2011-06-10 |
 BABY GORILLA 75705907 not registered Dead/Abandoned |
Baby Gorilla, Inc. 1999-05-13 |
 BABY GORILLA 73102081 1105097 Dead/Expired |
RICH BROTHERS CO. 1976-10-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.