Medicom SafeTouch 1129-B

GUDID 20686864001540

Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile - Clear - Medium

AMD Medicom Inc

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 20686864001540
• NIH Device Record Key: 8b4cf222-b5c8-457b-abce-d927434d3ae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medicom SafeTouch
• Version Model Number: 1129-B
• Catalog Number: 1129-B
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 100
• 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

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

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)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864001546 [Unit of Use]
GS1	10686864001543 [Primary]
GS1	20686864001540 [Package]; Contains: 10686864001543; Package: Outer case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182115

FDA Product Code

• LYZ: Vinyl Patient Examination Glove

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: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [Medicom SafeTouch]

• 20686864054720: MEDICOM SAFETOUCH DENTAL DAM
• 20686864054713: MEDICOM SAFETOUCH DENTAL DAM
• 00686864059592: Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile -
• 20686864014793: Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile -
• 20686864001557: Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile -
• 20686864001540: Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile -
• 20686864001526: Medicom SafeTouch EverStrong - Vinyl - Medical Examination Gloves - Powder-Free - Non-Sterile -
• 20686864047425: MEDICOM SAFETOUCH DENTAL DAM 6 X 6 Inch
• 20686864047395: MEDICOM SAFETOUCH DENTAL DAM 5 X 5 Inch
• 20686864047432: MEDICOM SAFETOUCH DENTAL DAM 6 X 6 Inch
• 20686864047371: MEDICOM SAFETOUCH DENTAL DAM 5 X 5 Inch
• 20686864047364: MEDICOM SAFETOUCH DENTAL DAM 5 X 5 Inch