Ocean Pacific Elements OPBIO-SP6

GUDID 00686864060741

Ocean Pacific Elements - Nitrile Examination Gloves - Biodegradable - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Blue - Sample pack

AMD Medicom Inc

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

• Primary Device ID: 00686864060741
• NIH Device Record Key: e6d1ab5a-e725-4de4-9d30-9e12f3202446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocean Pacific Elements
• Version Model Number: OPBIO-SP6
• Catalog Number: OPBIO-SP6
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 6
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00686864060741 [Unit of Use]
GS1	10686864060748 [Primary]

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: 2024-06-21
• Device Publish Date: 2024-06-13

Devices Manufactured by AMD Medicom Inc

• 20686864061162 - Medicom SafeSeal: 2025-03-28 Medicom SafeSeal Tan Steam Sterilization Indicator Tape - 0.75" x 60 yards
• 00686864061144 - MEDICOM DENTICARE: 2025-03-26 MEDICOM DENTICARE SWIVEL DPA, Sample Pack
• 00686864061151 - MEDICOM SAFEMATRIX: 2025-03-26 Medicom SafeMatrix, single use, sample pack
• 00686864061328 - MEDICOM: 2025-03-26 MEDICOM, Face Masks, sample pack
• 20686864061223 - MEDICOM SAFEWEAR: 2025-02-14 Medicom SafeWear Hipster Jacket - Jet Black - Premium Hip Length Jacket - Jet Black - 2X-Large
• 20686864056816 - Medicom SafeMask: 2025-01-31 Medicom SafeMask Architect - Procedure Earloop Face Masks - Level 3 - Blue
• 20686864058599 - Medicom SafeMask: 2025-01-31 Medicom SafeMask Architect JR - Pediatric Procedure Earloop Face Masks - Level 1 - Blue
• 20686864061278 - RITMED: 2025-01-14 Ritmed Precision - Isolation gown with over-the-head design - AAMI Level 2 - Yellow - Large