Primary Device ID | 07540194013514 |
NIH Device Record Key | 6ab9d0e9-7934-43f6-8d72-4f3f03175ddd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GIRO GROWTH MODULATION SYSTEM |
Version Model Number | GRO-TMP100 |
Catalog Number | GRO-TMP100 |
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 | 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@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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540194013514 [Primary] |
OBT | Plate, bone, growth control, pediatric, epiphysiodesis |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07540194013514]
Moist Heat or Steam Sterilization
[07540194013514]
Moist Heat or Steam Sterilization
[07540194013514]
Moist Heat or Steam Sterilization
[07540194013514]
Moist Heat or Steam Sterilization
[07540194013514]
Moist Heat or Steam Sterilization
[07540194013514]
Moist Heat or Steam Sterilization
[07540194013514]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-07 |
Device Publish Date | 2022-11-29 |
07540194014887 | Ø 6.0 x 80 mm, cannulated Ø 2.0 female post |
07540194014870 | Ø 6.0 x 75 mm, cannulated Ø 2.0 female post |
07540194014863 | Ø 6.0 x 70 mm, cannulated Ø 2.0 female post |
07540194014856 | Ø 6.0 x 65 mm, cannulated Ø 2.0 female post |
07540194014849 | Ø 6.0 x 60 mm, cannulated Ø 2.0 female post |
07540194014832 | Ø 6.0 x 55 mm, cannulated Ø 2.0 female post |
07540194014825 | Ø 6.0 x 50 mm, cannulated Ø 2.0 female post |
07540194014818 | Ø 6.0 x 45 mm, cannulated Ø 2.0 female post |
07540194014801 | Ø 6.0 x 40 mm, cannulated Ø 2.0 female post |
07540194014795 | Ø 6.0 x 35 mm, cannulated Ø 2.0 female post |
07540194014788 | Ø 6.0 x 30 mm, cannulated Ø 2.0 female post |
07540194014771 | Ø 6.0 x 35 mm, cannulated Ø 2.0 male post |
07540194014764 | Ø 6.0 x 35 mm, cannulated Ø 2.0 screw |
07540194014757 | Ø 6.0 x 30 mm, cannulated Ø 2.0 screw |
07540194014740 | Ø 6.0 x 25 mm, cannulated Ø 2.0 screw |
07540194014733 | Ø 6.0 x 20 mm, cannulated Ø 2.0 screw |
07540194014597 | 6.0 coupling assembled on the cable loop side |
07540194014580 | 6.0 coupling assembled on the cable bead side |
07540194014573 | Ø 4.5 x 70 mm, cannulated Ø 1.6 female post |
07540194014566 | Ø 4.5 x 65 mm, cannulated Ø 1.6 female post |
07540194014559 | Ø 4.5 x 60 mm, cannulated Ø 1.6 female post |
07540194014542 | Ø 4.5 x 55 mm, cannulated Ø 1.6 female post |
07540194014535 | Ø 4.5 x 50 mm, cannulated Ø 1.6 female post |
07540194014528 | Ø 4.5 x 45 mm, cannulated Ø 1.6 female post |
07540194014511 | Ø 4.5 x 40 mm, cannulated Ø 1.6 female post |
07540194014504 | Ø 4.5 x 35 mm, cannulated Ø 1.6 female post |
07540194014498 | Ø 4.5 x 30 mm, cannulated Ø 1.6 female post |
07540194014481 | Ø 4.5 x 25 mm, cannulated Ø 1.6 female post |
07540194014474 | Ø 4.5 x 20 mm, cannulated Ø 1.6 female post |
07540194014467 | Ø 4.5 x 35 mm, cannulated Ø 1.6 male post |
07540194014450 | Ø 4.5 x 25 mm, cannulated Ø 1.6 male post |
07540194014443 | Ø 4.5 x 35 mm, cannulated Ø 1.6 screw |
07540194014436 | Ø 4.5 x 30 mm, cannulated Ø 1.6 screw |
07540194014429 | Ø 4.5 x 25 mm, cannulated Ø 1.6 screw |
07540194014412 | Ø 4.5 x 20 mm, cannulated Ø 1.6 screw |
07540194014276 | 4.5 coupling assembled on the cable loop side |
07540194014269 | 4.5 coupling assembled on the cable bead side |
07540194015181 | DRILL Ø5.7mm CANNULATED |
07540194015174 | DRILL Ø4.5mm CANNULATED |
07540194015167 | DRILL Ø3.2mm CANNULATED |
07540194014252 | CANNULATED DRILL Ø4.2mm for 6.0 SCREW |
07540194013743 | FULL GIRO IMPLANT & INSTRUMENT CASE |
07540194013736 | FULL GIRO INSTRUMENT CASE |
07540194013729 | EMPTY GIRO IMPLANT & INSTRUMENT CASE |
07540194013712 | FULL GIRO IMPLANT CASE 6.0 |
07540194013705 | EMPTY GIRO IMPLANT CASE 6.0 |
07540194013699 | FULL GIRO IMPLANT CASE 4.5 |
07540194013682 | EMPTY GIRO IMPLANT CASE 4.5 |
07540194013675 | HORSESHOE KNOB |
07540194013668 | 6.0 HORSESHOE SLEEVE |