| Primary Device ID | 07540194004338 |
| NIH Device Record Key | 3ad5bf75-d12a-4621-9761-c54aa2468910 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HINGE PEDIATRIC PLATING SYSTEM |
| Version Model Number | HPS035-C-PKG2 |
| Catalog Number | HPS035-C-PKG2 |
| Company DUNS | 257315713 |
| Company Name | Pega Medical Inc |
| Device Count | 2 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540194004338 [Primary] |
| GS1 | 07540194004482 [Unit of Use] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
[07540194004338]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-07 |
| 07540194005946 | Hinge Plate Kit (Instrument & Implants) |
| 07540194004338 | Cannulated Screw 35mm Length |
| 07540194004321 | Cannulated Screw 30mm Length |
| 07540194004314 | Cannulated Screw 25mm Length |
| 07540194000705 | Cannulated Screw Ø4.5mm x 35mm Length |
| 07540194000699 | Cannulated Screw Ø4.5mm x 30mm Length |
| 07540194000682 | Cannulated Screw Ø4.5mm x 25mm Length |
| 07540194000675 | Cannulated Screw Ø4.5mm x 20mm Length |
| 07540194000668 | Screw Ø4.5mm x 35mm Length |
| 07540194000651 | Screw Ø4.5mm x 30mm Length |
| 07540194000644 | Screw Ø4.5mm x 25mm Length |
| 07540194000637 | Screw Ø4.5mm x 20mm Length |
| 07540194000620 | Screw Ø4.5mm x 35mm Length |
| 07540194000613 | Screw Ø4.5mm x 30mm Length |
| 07540194000606 | Screw Ø4.5mm x 25mm Length |
| 07540194000590 | Screw Ø4.5mm x 20mm Length |
| 07540194000583 | Large Plate 20mm Length |
| 07540194000576 | Medium Plate 16mm Length |
| 07540194000569 | Small Plate 12mm Length |
| 07540194009432 | FULL HINGE PLATE INSTRUMENT CASE RENTAL |
| 07540194009425 | FULL HINGE PLATE INSTRUMENT & IMPLANT CASE RENTAL |
| 07540194007735 | FULL HINGE PLATE INSTRUMENT CASE |
| 07540194007728 | HINGE PLATE TEMPLATE 20mm |
| 07540194007681 | HINGE PLATE CROC HOLDER |
| 07540194007674 | HINGE PLATE DUAL GUIDE |
| 07540194007667 | HINGE PLATE DRILL 3.0mm |
| 07540194007650 | CANNULATED HINGE PLATE SCREWDRIVER |
| 07540194007711 | HINGE PLATE TEMPLATE 16mm |
| 07540194007704 | HINGE PLATE TEMPLATE 12mm |
| 07540194007698 | HINGE PLATE SCREWDRIVER |
| 07540194007643 | EMPTY HINGE PLATE CASE |
| 07540194011961 | FULL HP SCREW CADDY |
| 07540194011954 | EMPTY HP SCREW CADDY |
| 07540194015891 | EMPTY HINGE PLATE IMPLANT CADDY -GEN2 |
| 07540194015877 | HP INSTRUMENTS ONLY -GEN2 |
| 07540194015846 | EMPTY HINGE PLATE CASE -GEN2 |
| 07540194015969 | HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2 -PACK OF 6 |
| 07540194015952 | HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2 - PACK OF 2 |
| 07540194015129 | HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2 |
| 07540194015112 | HINGE PLATE DRILL 3.0 MM -GEN2 |
| 07540194010742 | HINGE PLATE GUIDE WIRE Ø1.1mm- PACKAGE OF 6 |
| 07540194010735 | HINGE PLATE GUIDE WIRE Ø1.1mm- PACKAGE OF 2 |
| 07540194007742 | HINGE PLATE GUIDE WIRE Ø1.1mm |
| 07540194015228 | HINGE PLATE AO HANDLE -GEN2 |
| 07540194015150 | HINGE PLATE CROC HOLDER -GEN2 |
| 07540194015136 | HINGE PLATE SCREWDRIVER SHAFT -GEN2 |
| 07540194015105 | HINGE PLATE DUAL GUIDE -GEN2 |
| 07540194015068 | HINGE PLATE SNAP-ON SLEEVE -GEN2 |
| 07540194015907 | FULL HINGE PLATE IMPLANT CADDY -GEN2 |
| 07540194015853 | FULL HINGE PLATE CASE -GEN2 |