ML-CANADA DYNDCA1006A

GUDID 00653160366327

LACERATION TRAY

MEDLINE INDUSTRIES, INC.

Surgical/examination garment kit

• Primary Device ID: 00653160366327
• NIH Device Record Key: 88a89e39-98ba-4109-8bb4-18ca25b94222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ML-CANADA
• Version Model Number: DYNDCA1006A
• Catalog Number: DYNDCA1006A
• Company DUNS: 025460908
• Company Name: MEDLINE INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM
• Phone: +1(800)633-5463
• Email: CUSTOMERSERVICE@MEDLINE.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653160366327 [Package]; Contains: 10653160366324; Package: CASE [20 Units]; In Commercial Distribution
GS1	10653160366324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213481

FDA Product Code

• LRO: General surgery tray

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [ML-CANADA]

• 20193489110989: TOTE CHU OSC KNEE ARTHRSCPY
• 10889942692811: MYELOGRAM TRAY
• 40080196489832: PLASTIC TRANSFER FORCEPS STERL
• 40080196466864: STERILE TRACH BRUSH 1/PK
• 00653160366327: LACERATION TRAY
• 00653160364873: LACERATION TRAY
• 00653160370249: GENERAL PURPOSE TRAY
• 00653160376975: LACERATION TRAY