Primary Device ID | 07540194015952 |
NIH Device Record Key | f82243b9-35f8-4781-9aef-94b9a9fcce9d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HINGE PEDIATRIC PLATING SYSTEM |
Version Model Number | HP-GWR250-PKG2 |
Catalog Number | HP-GWR250-PKG2 |
Company DUNS | 257315713 |
Company Name | Pega Medical Inc |
Device Count | 2 |
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 | 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 |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Outer Diameter | 1.1 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540194015822 [Primary] |
GS1 | 07540194015952 [Unit of Use] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
[07540194015952]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-24 |
Device Publish Date | 2023-11-16 |
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 |