| Primary Device ID | 07540194005083 |
| NIH Device Record Key | 2da80b88-c74c-4ab4-a8e1-bcb9199e004c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Locking Pediatric Osteotomy Plate (LolliPOP) S |
| Version Model Number | POP-OB45-60 |
| Catalog Number | POP-OB45-60 |
| Company DUNS | 257315713 |
| Company Name | Pega Medical Inc |
| Device Count | 1 |
| 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 |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 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 | 07540194005083 [Primary] |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
Moist Heat or Steam Sterilization
[07540194005083]
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 | 2017-11-03 |
| 07540194006684 | Locking Screw, Ø2.7 X 12mm |
| 07540194006677 | Locking Screw, Ø3.5 X 12mm |
| 07540194006660 | Locking Screw, Ø4.5 X 12mm |
| 07540194006653 | Polyaxial Compression Screw, Ø2.7 X 26mm |
| 07540194006646 | Polyaxial Compression Screw, Ø2.7 X 22mm |
| 07540194006639 | Polyaxial Compression Screw, Ø2.7 X 18mm |
| 07540194006622 | Polyaxial Compression Screw, Ø2.7 X 14mm |
| 07540194006615 | Polyaxial Compression Screw, Ø3.5 X 26mm |
| 07540194006608 | Polyaxial Compression Screw, Ø3.5 X 22mm |
| 07540194006592 | Polyaxial Compression Screw, Ø3.5 X 18mm |
| 07540194006585 | Polyaxial Compression Screw, Ø3.5 X 14mm |
| 07540194006578 | Polyaxial Compression Screw, Ø4.5 X 26mm |
| 07540194006561 | Polyaxial Compression Screw, Ø4.5 X 22mm |
| 07540194006554 | Polyaxial Compression Screw, Ø4.5 X 18mm |
| 07540194006547 | Polyaxial Compression Screw, Ø4.5 X 14mm |
| 07540194006059 | Polyaxial Compression Screw, Ø2.7 X 16mm |
| 07540194006042 | Varus Plate, Infant 120° |
| 07540194006035 | Polyaxial Compression Screw, Ø3.5 X 16mm |
| 07540194006028 | Varus Plate, Child 120° |
| 07540194006004 | Polyaxial Compression Screw, Ø2.7 X 12mm |
| 07540194005991 | Polyaxial Compression Screw, Ø3.5 X 12mm |
| 07540194005984 | Polyaxial Compression Screw, Ø4.5 X 16mm |
| 07540194005977 | Polyaxial Compression Screw, Ø4.5 X 12mm |
| 07540194005960 | Varus Plate, Adolescent 120° |
| 07540194005953 | Varus Plate, HD Adolescent 120° |
| 07540194005939 | Implant Case -Full |
| 07540194005922 | Polyaxial Compression Screw, Ø2.7 X 60mm |
| 07540194005915 | Polyaxial Compression Screw, Ø2.7 X 56mm |
| 07540194005908 | Polyaxial Compression Screw, Ø2.7 X 52mm |
| 07540194005892 | Polyaxial Compression Screw, Ø2.7 X 48mm |
| 07540194005885 | Polyaxial Compression Screw, Ø2.7 X 44mm |
| 07540194005878 | Polyaxial Compression Screw, Ø2.7 X 40mm |
| 07540194005861 | Polyaxial Compression Screw, Ø2.7 X 36mm |
| 07540194005854 | Polyaxial Compression Screw, Ø2.7 X 32mm |
| 07540194005847 | Polyaxial Compression Screw, Ø2.7 X 28mm |
| 07540194005830 | Polyaxial Compression Screw, Ø2.7 X 24mm |
| 07540194005823 | Polyaxial Compression Screw, Ø2.7 X 20mm |
| 07540194005816 | Locking Screw, Ø2.7 X 40mm |
| 07540194005809 | Locking Screw, Ø2.7 X 36mm |
| 07540194005793 | Locking Screw, Ø2.7 X 32mm |
| 07540194005786 | Locking Screw, Ø2.7 X 28mm |
| 07540194005779 | Locking Screw, Ø2.7 X 26mm |
| 07540194005762 | Locking Screw, Ø2.7 X 24mm |
| 07540194005755 | Locking Screw, Ø2.7 X 22mm |
| 07540194005748 | Locking Screw, Ø2.7 X 20mm |
| 07540194005731 | Locking Screw, Ø2.7 X 18mm |
| 07540194005724 | Locking Screw, Ø2.7 X 16mm |
| 07540194005717 | Locking Screw, Ø2.7 X 14mm |
| 07540194005700 | Blade, Infant 35mm |
| 07540194005694 | Blade, Infant 30mm |