Primary Device ID | 07540194010865 |
NIH Device Record Key | 345efad3-65c2-4a0c-a4ae-8a5e8b41d3e3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FREE GLIDING SCFE SCREW SYSTEM |
Version Model Number | SCF-GWR328-CoCr-PKG6 |
Catalog Number | SCF-GWR328-CoCr-PKG6 |
Company DUNS | 257315713 |
Company Name | Pega Medical Inc |
Device Count | 6 |
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 | 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 | |
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 | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 Millimeter |
Outer Diameter | 2.8 Millimeter |
Length | 330 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540194008282 [Primary] |
GS1 | 07540194010865 [Unit of Use] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
Moist Heat or Steam Sterilization
[07540194010865]
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 |
07540194006011 | COMBINED SCFE CASE, 3rd Gen. |
07540194004451 | FULL SCFE IMPLANT & INSTRUMENT CASE 2nd Gen. |
07540194004376 | FULL MINI SCFE IMPLANT CASE |
07540194004369 | FULL SCFE IMPLANT & INSTRUMENT CASE |
07540194004307 | Female Component 100/102mm Ø7.3mm |
07540194004291 | Female Component 100/102mm Ø6.5mm |
07540194002594 | Male Component Ø6.5mm Short |
07540194002587 | Male Component Ø6.5mm Long |
07540194002570 | Cap Ø7.3mm |
07540194002563 | Female Component 96/98mm Ø7.3mm |
07540194002556 | Female Component 92/94mm Ø7.3mm |
07540194002549 | Female Component 88/90mm Ø7.3mm |
07540194002532 | Female Component 84/86mm Ø7.3mm |
07540194002525 | Female Component 80/82mm Ø7.3mm |
07540194002518 | Female Component 76/78mm Ø7.3mm |
07540194002501 | Female Component 72/74mm Ø7.3mm |
07540194002495 | Female Component 68/70mm Ø7.3mm |
07540194002488 | Female Component 64/66mm Ø7.3mm |
07540194002471 | Female Component 60/62mm Ø7.3mm |
07540194002464 | Mini Female Component 56/58mm Ø7.3mm |
07540194002457 | Mini Female Component 52/54mm Ø7.3mm |
07540194002440 | Mini Female Component 48/50mm Ø7.3mm |
07540194002433 | Mini Male Component Ø7.3mm Short |
07540194002426 | Mini Male Component Ø7.3mm Long |
07540194002419 | Male Component Ø7.3mm Short |
07540194002402 | Male Component Ø7.3mm Long |
07540194002396 | Cap Ø6.5mm |
07540194002389 | Female Component 96/98mm Ø6.5mm |
07540194002372 | Female Component 92/94mm Ø6.5mm |
07540194002365 | Female Component 88/90mm Ø6.5mm |
07540194002358 | Female Component 84/86mm Ø6.5mm |
07540194002341 | Female Component 80/82mm Ø6.5mm |
07540194002334 | Female Component 76/78mm Ø6.5mm |
07540194002327 | Female Component 72/74mm Ø6.5mm |
07540194002310 | Female Component 68/70mm Ø6.5mm |
07540194002303 | Female Component 64/66mm Ø6.5mm |
07540194002297 | Female Component 60/62mm Ø6.5mm |
07540194002280 | Mini Female Component 56/58mm Ø6.5mm |
07540194002273 | Mini Female Component 52/54mm Ø6.5mm |
07540194002266 | Mini Female Component 48/50mm Ø6.5mm |
07540194002259 | Mini Male Component Ø6.5mm Short |
07540194002242 | Mini Male Component Ø6.5mm Long |
07540194010988 | SCFE HANDLE-SHAFT SUBASSY Ø7.3mm - MINI |
07540194010971 | SCFE HANDLE-SHAFT SUBASSY Ø6.5mm - MINI |
07540194009715 | FULL SCFE IMPLANT & INSTRUMENT CASE RENTAL - GENERATION III |
07540194009708 | FULL SCFE IMPLANT & INSTRUMENT CASE RENTAL – GENERATION II |
07540194009692 | FULL MINI SCFE IMPLANT CASE RENTAL |
07540194010865 | SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 6 |
07540194010858 | SCFE GUIDE WIRE CoCr Ø2.80mm - PACKAGE OF 2 |
07540194008268 | SCFE GUIDE WIRE CoCr Ø2.80mm x 330mm |