Powered Cole Isolation Device 900.000

GUDID 00810072350961

Powered Cole Isolation Device. Sterilize handpiece nosecone before first use and before each use.

Cole Instruments Inc

Electrical breakout box

• Primary Device ID: 00810072350961
• NIH Device Record Key: 7dc961ba-5b30-42ce-a6c9-c9b6264411b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powered Cole Isolation Device
• Version Model Number: PCID
• Catalog Number: 900.000
• Company DUNS: 078573265
• Company Name: Cole Instruments Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 84.3 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810072350961 [Primary]

FDA Product Code

• GEY: Motor, Surgical Instrument, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-12
• Device Publish Date: 2021-02-04

Devices Manufactured by Cole Instruments Inc

• 00810072351159 - Graft Storage Plate: 2023-11-03 A plate that cools and holds follicles until the follicles are ready for donation on the recipient area of the human forhead.
• 00810072351142 - ATOE-Stainless Steel: 2022-08-05 Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles after being punches.
• 00810072350831 - Tweezers: 2021-12-22 Tweezers
• 00810072350862 - Donor template: 2021-12-22 Donor template
• 00810072350879 - AHSAD: 2021-12-22 Assist to Hairline Surface Area Determination. Can assist in surface for donor or receipient area.
• 00810072350947 - Graft Board Round LED Backlight: 2021-12-22 Round LED back light used for Graft Boards in processing
• 00810072350954 - Graft Cleaning Bowl: 2021-12-22 Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient are
• 00810072350008 - 1.30 mm regular punch, 5 pack: 2021-02-12 1.30 mm regular punch, 5 pack