HINGE PEDIATRIC PLATING SYSTEM HPI012

GUDID 07540194000569

Small Plate 12mm Length

Pega Medical Inc

Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit

• Primary Device ID: 07540194000569
• NIH Device Record Key: 85b5c9f8-635d-41b8-a6ec-22142816d8ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HINGE PEDIATRIC PLATING SYSTEM
• Version Model Number: HPI012
• Catalog Number: HPI012
• 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

Customer Support Contacts

• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com
• Phone: +1(450)688-5144
• Email: egarcia@pegamedical.com

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07540194000569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090440

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07540194000569]

Moist Heat or Steam Sterilization

[07540194000569]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-20

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• 07540194004321: Cannulated Screw 30mm Length
• 07540194004314: Cannulated Screw 25mm Length
• 07540194000705: Cannulated Screw Ø4.5mm x 35mm Length
• 07540194000699: Cannulated Screw Ø4.5mm x 30mm Length
• 07540194000682: Cannulated Screw Ø4.5mm x 25mm Length
• 07540194000675: Cannulated Screw Ø4.5mm x 20mm Length
• 07540194000668: Screw Ø4.5mm x 35mm Length
• 07540194000651: Screw Ø4.5mm x 30mm Length
• 07540194000644: Screw Ø4.5mm x 25mm Length
• 07540194000637: Screw Ø4.5mm x 20mm Length
• 07540194000620: Screw Ø4.5mm x 35mm Length
• 07540194000613: Screw Ø4.5mm x 30mm Length
• 07540194000606: Screw Ø4.5mm x 25mm Length
• 07540194000590: Screw Ø4.5mm x 20mm Length
• 07540194000583: Large Plate 20mm Length
• 07540194000576: Medium Plate 16mm Length
• 07540194000569: Small Plate 12mm Length
• 07540194009432: FULL HINGE PLATE INSTRUMENT CASE RENTAL
• 07540194009425: FULL HINGE PLATE INSTRUMENT & IMPLANT CASE RENTAL
• 07540194007735: FULL HINGE PLATE INSTRUMENT CASE
• 07540194007728: HINGE PLATE TEMPLATE 20mm
• 07540194007681: HINGE PLATE CROC HOLDER
• 07540194007674: HINGE PLATE DUAL GUIDE
• 07540194007667: HINGE PLATE DRILL 3.0mm
• 07540194007650: CANNULATED HINGE PLATE SCREWDRIVER
• 07540194007711: HINGE PLATE TEMPLATE 16mm
• 07540194007704: HINGE PLATE TEMPLATE 12mm
• 07540194007698: HINGE PLATE SCREWDRIVER
• 07540194007643: EMPTY HINGE PLATE CASE
• 07540194011961: FULL HP SCREW CADDY
• 07540194011954: EMPTY HP SCREW CADDY
• 07540194015891: EMPTY HINGE PLATE IMPLANT CADDY -GEN2
• 07540194015877: HP INSTRUMENTS ONLY -GEN2
• 07540194015846: EMPTY HINGE PLATE CASE -GEN2
• 07540194015969: HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2 -PACK OF 6
• 07540194015952: HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2 - PACK OF 2
• 07540194015129: HINGE PLATE GUIDE WIRE Ø1.1mm -GEN2
• 07540194015112: HINGE PLATE DRILL 3.0 MM -GEN2
• 07540194010742: HINGE PLATE GUIDE WIRE Ø1.1mm- PACKAGE OF 6
• 07540194010735: HINGE PLATE GUIDE WIRE Ø1.1mm- PACKAGE OF 2
• 07540194007742: HINGE PLATE GUIDE WIRE Ø1.1mm
• 07540194015228: HINGE PLATE AO HANDLE -GEN2
• 07540194015150: HINGE PLATE CROC HOLDER -GEN2
• 07540194015136: HINGE PLATE SCREWDRIVER SHAFT -GEN2
• 07540194015105: HINGE PLATE DUAL GUIDE -GEN2
• 07540194015068: HINGE PLATE SNAP-ON SLEEVE -GEN2