GIRO GROWTH MODULATION SYSTEM GRO-IME100-60

GUDID 07540194013705

EMPTY GIRO IMPLANT CASE 6.0

Pega Medical Inc

Growth-correction orthopaedic fixation plate kit
Primary Device ID07540194013705
NIH Device Record Keyafe10393-f3ec-4e6b-ab4e-35918909c71e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIRO GROWTH MODULATION SYSTEM
Version Model NumberGRO-IME100-60
Catalog NumberGRO-IME100-60
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194013705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194013705]

Moist Heat or Steam Sterilization

[07540194013705]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

On-Brand Devices [GIRO GROWTH MODULATION SYSTEM]

07540194014887Ø 6.0 x 80 mm, cannulated Ø 2.0 female post
07540194014870Ø 6.0 x 75 mm, cannulated Ø 2.0 female post
07540194014863Ø 6.0 x 70 mm, cannulated Ø 2.0 female post
07540194014856Ø 6.0 x 65 mm, cannulated Ø 2.0 female post
07540194014849Ø 6.0 x 60 mm, cannulated Ø 2.0 female post
07540194014832Ø 6.0 x 55 mm, cannulated Ø 2.0 female post
07540194014825Ø 6.0 x 50 mm, cannulated Ø 2.0 female post
07540194014818Ø 6.0 x 45 mm, cannulated Ø 2.0 female post
07540194014801Ø 6.0 x 40 mm, cannulated Ø 2.0 female post
07540194014795Ø 6.0 x 35 mm, cannulated Ø 2.0 female post
07540194014788Ø 6.0 x 30 mm, cannulated Ø 2.0 female post
07540194014771Ø 6.0 x 35 mm, cannulated Ø 2.0 male post
07540194014764Ø 6.0 x 35 mm, cannulated Ø 2.0 screw
07540194014757Ø 6.0 x 30 mm, cannulated Ø 2.0 screw
07540194014740Ø 6.0 x 25 mm, cannulated Ø 2.0 screw
07540194014733Ø 6.0 x 20 mm, cannulated Ø 2.0 screw
075401940145976.0 coupling assembled on the cable loop side
075401940145806.0 coupling assembled on the cable bead side
07540194014573Ø 4.5 x 70 mm, cannulated Ø 1.6 female post
07540194014566Ø 4.5 x 65 mm, cannulated Ø 1.6 female post
07540194014559Ø 4.5 x 60 mm, cannulated Ø 1.6 female post
07540194014542Ø 4.5 x 55 mm, cannulated Ø 1.6 female post
07540194014535Ø 4.5 x 50 mm, cannulated Ø 1.6 female post
07540194014528Ø 4.5 x 45 mm, cannulated Ø 1.6 female post
07540194014511Ø 4.5 x 40 mm, cannulated Ø 1.6 female post
07540194014504Ø 4.5 x 35 mm, cannulated Ø 1.6 female post
07540194014498Ø 4.5 x 30 mm, cannulated Ø 1.6 female post
07540194014481Ø 4.5 x 25 mm, cannulated Ø 1.6 female post
07540194014474Ø 4.5 x 20 mm, cannulated Ø 1.6 female post
07540194014467Ø 4.5 x 35 mm, cannulated Ø 1.6 male post
07540194014450Ø 4.5 x 25 mm, cannulated Ø 1.6 male post
07540194014443Ø 4.5 x 35 mm, cannulated Ø 1.6 screw
07540194014436Ø 4.5 x 30 mm, cannulated Ø 1.6 screw
07540194014429Ø 4.5 x 25 mm, cannulated Ø 1.6 screw
07540194014412Ø 4.5 x 20 mm, cannulated Ø 1.6 screw
075401940142764.5 coupling assembled on the cable loop side
075401940142694.5 coupling assembled on the cable bead side
07540194015181DRILL Ø5.7mm CANNULATED
07540194015174DRILL Ø4.5mm CANNULATED
07540194015167DRILL Ø3.2mm CANNULATED
07540194014252CANNULATED DRILL Ø4.2mm for 6.0 SCREW
07540194013743FULL GIRO IMPLANT & INSTRUMENT CASE
07540194013736FULL GIRO INSTRUMENT CASE
07540194013729EMPTY GIRO IMPLANT & INSTRUMENT CASE
07540194013712FULL GIRO IMPLANT CASE 6.0
07540194013705EMPTY GIRO IMPLANT CASE 6.0
07540194013699FULL GIRO IMPLANT CASE 4.5
07540194013682EMPTY GIRO IMPLANT CASE 4.5
07540194013675HORSESHOE KNOB
075401940136686.0 HORSESHOE SLEEVE
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