| Primary Device ID | 07540194010018 |
| NIH Device Record Key | 98d5e393-efe1-49e4-a6b1-9784520d844c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GAP ENDO-EXO MEDULLARY SYSTEM |
| Version Model Number | GAP-KNB200 |
| Catalog Number | GAP-KNB200 |
| Company DUNS | 257315713 |
| Company Name | Pega Medical Inc |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca | |
| Phone | +1(450)688-5144 |
| egarcia@orthopediatrics.ca |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540194010018 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
Moist Heat or Steam Sterilization
[07540194010018]
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 |
| 07540194004857 | Cortical Peg & Washer Ø2.5mm X 80mm |
| 07540194004840 | Cortical Peg & Washer Ø2.5mm X 75mm |
| 07540194004833 | Cortical Peg & Washer Ø2.5mm X 70mm |
| 07540194004826 | Cortical Peg & Washer Ø2.5mm X 65mm |
| 07540194004819 | Cortical Peg & Washer Ø2.5mm X 55mm |
| 07540194004802 | Cortical Peg & Washer Ø2.5mm X 50mm |
| 07540194004796 | Cortical Peg & Washer Ø2.5mm X 45mm |
| 07540194004789 | Cortical Peg & Washer Ø2.5mm X 40mm |
| 07540194004772 | Cortical Peg & Washer Ø2.5mm X 38mm |
| 07540194004765 | Cortical Peg & Washer Ø2.5mm X 36mm |
| 07540194004758 | Cortical Peg & Washer Ø2.5mm X 34mm |
| 07540194004741 | Cortical Peg & Washer Ø2.5mm X 32mm |
| 07540194004734 | Cortical Peg & Washer Ø2.5mm X 30mm |
| 07540194004727 | Cortical Peg & Washer Ø2.5mm X 28mm |
| 07540194004710 | Cortical Peg & Washer Ø2.5mm X 26mm |
| 07540194004703 | Cortical Peg & Washer Ø2.5mm X 24mm |
| 07540194004697 | Cortical Peg & Washer Ø2.5mm X 22mm |
| 07540194004680 | Cortical Peg & Washer Ø2.5mm X 20mm |
| 07540194004673 | Cortical Peg Ø2.5mm X 80mm |
| 07540194004666 | Cortical Peg Ø2.5mm X 75mm |
| 07540194004659 | Cortical Peg Ø2.5mm X 70mm |
| 07540194004642 | Cortical Peg Ø2.5mm X 65mm |
| 07540194004635 | Cortical Peg Ø2.5mm X 55mm |
| 07540194004628 | Cortical Peg Ø2.5mm X 50mm |
| 07540194004611 | Cortical Peg Ø2.5mm X 45mm |
| 07540194004604 | Cortical Peg Ø2.5mm X 40mm |
| 07540194004598 | Cortical Peg Ø2.5mm X 38mm |
| 07540194004581 | Cortical Peg Ø2.5mm X 36mm |
| 07540194004574 | Cortical Peg Ø2.5mm X 34mm |
| 07540194004567 | Cortical Peg Ø2.5mm X 32mm |
| 07540194004550 | Cortical Peg Ø2.5mm X 30mm |
| 07540194004543 | Cortical Peg Ø2.5mm X 28mm |
| 07540194004536 | Cortical Peg Ø2.5mm X 26mm |
| 07540194004529 | Cortical Peg Ø2.5mm X 24mm |
| 07540194004512 | Cortical Peg Ø2.5mm X 22mm |
| 07540194004505 | Cortical Peg Ø2.5mm X 20mm |
| 07540194004499 | Cortical Peg & Washer Ø2.5mm X 60mm |
| 07540194004352 | FULL GAP IMPLANT CASE |
| 07540194004345 | Cortical Peg Ø2.5mm X 60mm |
| 07540194002235 | Semi-Spherical Nut A/F 6.0mm |
| 07540194002228 | Short Fixation Plate |
| 07540194002211 | Long Fixation Plate |
| 07540194002204 | Nail Cap 10.0mm High |
| 07540194002198 | Nail Cap 5.0mm High |
| 07540194002181 | Nail Cap 1.5mm High |
| 07540194002174 | Mechanical Screw Ø4.0mm X 34mm |
| 07540194002167 | Mechanical Screw Ø4.0mm X 24mm |
| 07540194002150 | Coxa Vara Plate Large |
| 07540194002143 | Coxa Vara Plate Medium |
| 07540194002136 | Coxa Vara Plate Small |