CUSMED FACE MASK

GUDID 14717002404387

3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use

OSSAWARE BIOTECH CO., LTD.

Surgical/medical face mask, single-use

• Primary Device ID: 14717002404387
• NIH Device Record Key: 5ce5d6ac-50e1-4299-b39d-c55212a65190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSMED FACE MASK
• Version Model Number: 9600.0000.00
• Company DUNS: 656747172
• Company Name: OSSAWARE BIOTECH CO., LTD.
• Device Count: 1
• 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: true
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM
• Phone: +88647977428
• Email: FDA@CUSMED.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04717002404380 [Primary]
GS1	14717002404387 [Package]; Contains: 04717002404380; Package: Box [50 Units]; Discontinued: 2021-03-23; Not in Commercial Distribution
GS1	24717002404384 [Package]; Package: Shipping carton [50 Units]; Discontinued: 2021-03-23; Not in Commercial Distribution

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2021-03-31
• Device Publish Date: 2021-03-23

Devices Manufactured by OSSAWARE BIOTECH CO., LTD.

• 14717002404387 - CUSMED FACE MASK: 2021-03-31 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use
• 14717002404387 - CUSMED FACE MASK: 2021-03-31 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use
• 14717002404165 - CirFIX® Cranial bone fixation system: Flap Fixator: 2020-10-06 Flap Fixator, Low Profile Replaceable Type, PEEK, D15mm, Sterile
• 14717002404172 - CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS): 2020-10-06 Flap Fixator, Low Profile Replaceable Type, PEEK, D15mm, Sterile (3 PCS)
• 14717002404325 - CirFIX® Cranial bone fixation system: Burr Hole Cover: 2020-10-06 CirFIX® Burr Hole Cover, Radiolucent Revisable Type, PEEK, 14mm/11mm, Sterile
• 04717002404335 - CirFIX® Cranial bone fixation system: Burr Hole Cover: 2020-09-22 CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP, PEEK, 14mm/11mm, Sterile