PurePRP Supraphysiologic 120mL GenesisCS Component Concentrating System GS120-SP

GUDID 00855306003701

EMCYTE CORP.

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Primary Device ID	00855306003701
NIH Device Record Key	817bfccf-95a2-4ff4-b81f-ccf93422973b
Commercial Distribution Status	In Commercial Distribution
Brand Name	PurePRP Supraphysiologic 120mL GenesisCS Component Concentrating System
Version Model Number	GS120-SP
Catalog Number	GS120-SP
Company DUNS	021599728
Company Name	EMCYTE CORP.
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com
Phone	+1(239)482-7725
Email	support@emcyte.com

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855306003701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

BK050055

FDA Product Code

JQC	CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
ORG	Platelet and plasma separator for bone graft handling

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

[00855306003701]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-04-09
Device Publish Date	2019-01-08

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