Sil.Flex TC Pad 5 mm

GUDID 64710810117598

GALEMED CORPORATION

Laryngectomy tube, sterile

• Primary Device ID: 64710810117598
• NIH Device Record Key: 1569064d-780c-4b09-925e-587d5ecd5e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sil.Flex
• Version Model Number: DP00
• Catalog Number: TC Pad 5 mm
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• Device Count: 10
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	24710810117590 [Primary]
GS1	64710810117598 [Package]; Contains: 24710810117590; Package: Carton [16 Units]; In Commercial Distribution
GS1	94710810117599 [Unit of Use]

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-15

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