Primary Device ID | 07540194002143 |
NIH Device Record Key | f5d62851-54ef-4daa-a23a-3d40185455e5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GAP ENDO-EXO MEDULLARY SYSTEM |
Version Model Number | GAP-PLC120 |
Catalog Number | GAP-PLC120 |
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 | |
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 |
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 | 07540194002143 [Primary] |
HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
[07540194002143]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-10-20 |
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 |