GIRO GROWTH MODULATION SYSTEM GRO-A45-030

GUDID 07540194014351

4.5 GIRO 30mm

Pega Medical Inc

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

Primary Device ID	07540194014351
NIH Device Record Key	90697836-7a54-41ab-accd-9b4f282eaf54
Commercial Distribution Status	In Commercial Distribution
Brand Name	GIRO GROWTH MODULATION SYSTEM
Version Model Number	GRO-A45-030
Catalog Number	GRO-A45-030
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@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca
Phone	+1(450)688-5144
Email	egarcia@orthopediatrics.ca

Device Dimensions

Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 Millimeter
Length	30 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
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 Identifiers

Device Issuing Agency	Device ID
GS1	07540194014351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K220190

FDA Product Code

HWC	Screw, fixation, bone