| Primary Device ID | 07540194010902 |
| NIH Device Record Key | 9a7accbc-5983-43f9-88c3-68d9e92e2d22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Locking Pediatric Osteotomy Plate (LolliPOP) System |
| Version Model Number | POP-GWR120-PKG6 |
| Catalog Number | POP-GWR120-PKG6 |
| Company DUNS | 257315713 |
| Company Name | Pega Medical Inc |
| Device Count | 6 |
| 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 | false |
| Serial Number | true |
| 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 | |
| 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 | |
| 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 | |
| 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 | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 Millimeter |
| Length | 254 Millimeter |
| Outer Diameter | 2 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 |
| 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 |
| 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 |
| 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 | 07540194010445 [Primary] |
| GS1 | 07540194010902 [Unit of Use] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
[07540194010902]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-20 |
| Device Publish Date | 2020-08-12 |
| 07540194006707 | M4 Connector For Child |
| 07540194006691 | M3 Connector For Infant |
| 07540194008824 | FULL LOLLIPOP INFANT/CHILD SCREW CADDY |
| 07540194008817 | FULL LOLLIPOP ADO/HD SCREW CADDY |
| 07540194008800 | FULL LOLLIPOP INFANT/CHILD IMPLANT CASE |
| 07540194008794 | FULL LOLLIPOP ADO/HD IMPLANT CASE |
| 07540194008787 | CONNECTOR FOR ADOLESCENT & HD ADOLESCENT |
| 07540194010919 | LOLLIPOP DEROTATION PIN Ø2.8 - PACKAGE OF 2 |
| 07540194010902 | LOLLIPOP GUIDE WIRE Ø2.0mm - PACKAGE OF 6 |
| 07540194010926 | LOLLIPOP DEROTATION PIN Ø2.8 - PACKAGE OF 6 |
| 07540194010896 | LOLLIPOP GUIDE WIRE Ø2.0mm - PACKAGE OF 2 |
| 07540194009388 | LOLLIPOP INSTRUMENT CASE ADO/ADO HD RENTAL |
| 07540194009371 | LOLLIPOP INSTRUMENT CASE INFANT/CHILD RENTAL |
| 07540194009357 | WIRE GUIDE |
| 07540194009340 | VERBRUGGE INFANT |
| 07540194009333 | VERBRUGGE CHILD |
| 07540194009326 | VERBRUGGE ADO/ADO HD |
| 07540194009319 | POSITIONING TRIANGLE, 110-60-10° |
| 07540194009302 | POSITIONING TRIANGLE, 100-60-20° |
| 07540194009296 | POSITIONING TRIANGLE, 90-50-40° |
| 07540194009289 | POSITIONING TRIANGLE, 80-70-30° |
| 07540194009272 | ADO/ADO HD LOCKING SLEEVE, Ø4.5mm |
| 07540194009265 | CHILD LOCKING SLEEVE, Ø3.5mm |
| 07540194009258 | INFANT LOCKING SLEEVE, Ø2.7mm |
| 07540194009241 | SLAP HAMMER |
| 07540194009234 | CONNECTOR SHAFT, ADO/ADO HD |
| 07540194009227 | CONNECTOR SHAFT, CHILD |
| 07540194009210 | CONNECTOR SHAFT, INFANT |
| 07540194009203 | OSTEOTOMY GUIDE, VALGUS ADO HD |
| 07540194009197 | OSTEOTOMY GUIDE, VALGUS ADO |
| 07540194009180 | OSTEOTOMY GUIDE, VALGUS CHILD |
| 07540194009173 | OSTEOTOMY GUIDE, VALGUS INFANT |
| 07540194009166 | DRILL GUIDE FOR ADO Ø4.5mm SCREWS |
| 07540194009159 | DRILL GUIDE FOR CHILD Ø3.5mm SCREWS |
| 07540194009142 | DRILL GUIDE FOR INFANT Ø2.7mm SCREWS |
| 07540194009135 | BLADE JOYSTICK, ADO/ADO HD |
| 07540194009128 | BLADE JOYSTICK, CHILD |
| 07540194009111 | BLADE JOYSTICK, INFANT |
| 07540194009104 | FULL LOLLIPOP INFANT/CHILD INSTRUMENT CASE |
| 07540194009098 | FULL LOLLIPOP ADO/ADO HD INSTRUMENT CASE |
| 07540194009081 | EMPTY LOLLIPOP INFANT/CHILD INSTRUMENT CASE |
| 07540194009074 | EMPTY LOLLIPOP ADO/ADO HD INSTRUMENT CASE |
| 07540194009067 | IMPACTION DRIVER |
| 07540194009050 | EMPTY LOLLIPOP INFANT/CHILD IMPLANT CASE |
| 07540194009043 | EMPTY LOLLIPOP ADO/ADO HD IMPLANT CASE |
| 07540194009036 | HANDLE |
| 07540194009029 | LOLLIPOP DEROTATION PIN Ø2.8 |
| 07540194009012 | LOLLIPOP GUIDE WIRE Ø2.0 x 254mm |
| 07540194009005 | FLEXION-EXTENSION GUIDE |
| 07540194008992 | DEROTATION GUIDE |