Ocean Pacific OPM-BIO

GUDID 20686864060257

Ocean Pacific Elements - Nitrile Examination Gloves - Biodegradable - Recyclable Packaging, Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Blue - Medium

AMD Medicom Inc

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 20686864060257
• NIH Device Record Key: 17ac7da7-9722-45e1-8bef-0c94a3c84eb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocean Pacific
• Version Model Number: OPM-BIO
• Catalog Number: OPM-BIO
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 200
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864060253 [Unit of Use]
GS1	10686864060250 [Primary]
GS1	20686864060257 [Package]; Contains: 10686864060250; Package: Outer case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200581

FDA Product Code

• LZC: Patient Examination Glove, Specialty

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: 2023-08-08
• Device Publish Date: 2023-07-31

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