Cryotec TEC104Y

GUDID 04589700010183

Kitazato Cryotec (4 pieces) (Yellow)

REPROLIFE INC.

Tissue storage straw

• Primary Device ID: 04589700010183
• NIH Device Record Key: 64faab32-86c8-4f83-8be3-e992889ef550
• Commercial Distribution Discontinuation: 2017-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cryotec
• Version Model Number: TEC104Y
• Catalog Number: TEC104Y
• Company DUNS: 691176883
• Company Name: REPROLIFE INC.
• Device Count: 4
• 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

• Handling 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	00045897000118 [Unit of Use]
GS1	04589700010183 [Primary]
GS1	45897000118018 [Unit of Use]

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: 4
• Public Version Date: 2019-07-10
• Device Publish Date: 2017-08-31

On-Brand Devices [Cryotec]

• 04589700010206: Kitazato Cryotec (4 pieces) (White)
• 04589700010190: Kitazato Cryotec (4 pieces) (Green)
• 04589700010183: Kitazato Cryotec (4 pieces) (Yellow)
• 04589700010176: Kitazato Cryotec (4 pieces) (Red)
• 04589700010169: Kitazato Cryotec (4 pieces) (Blue)
• 04589700010152: Cryotec (4 pieces) (White)
• 04589700010145: Cryotec (4 pieces) (Green)
• 04589700010138: Cryotec (4 pieces) (Yellow)
• 04589700010121: Cryotec (4 pieces) (Red)
• 04589700010114: Cryotec (4 pieces) (Blue)
• 04589700010107: Kitazato Cryotec (10 pieces) (White)
• 04589700010091: Kitazato Cryotec (10 pieces) (Green)
• 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)