Cryotec TEC010W

GUDID 04589700010053

Cryotec (10 pieces) (White)

REPROLIFE INC.

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Primary Device ID	04589700010053
NIH Device Record Key	1d2e3978-98a0-463a-94b6-30c85652ccb7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cryotec
Version Model Number	TEC010W
Catalog Number	TEC010W
Company DUNS	691176883
Company Name	REPROLIFE INC.
Device Count	10
DM Exempt	false
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	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

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00045897000105 [Unit of Use]
GS1	04589700010053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162051

FDA Product Code

MQK	Labware, Assisted Reproduction

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-08-31

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04589700010176	Kitazato Cryotec (4 pieces) (Red)
04589700010169	Kitazato Cryotec (4 pieces) (Blue)
04589700010152	Cryotec (4 pieces) (White)
04589700010145	Cryotec (4 pieces) (Green)
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04589700010084	Kitazato Cryotec (10 pieces) (Yellow)
04589700010077	Kitazato Cryotec (10 pieces) (Red)
04589700010060	Kitazato Cryotec (10 pieces) (Blue)
04589700010053	Cryotec (10 pieces) (White)
04589700010046	Cryotec (10 pieces) (Green)
04589700010039	Cryotec (10 pieces) (Yellow)
04589700010022	Cryotec (10 pieces) (Red)
04589700010015	Cryotec (10 pieces) (Blue)