FDA.reportPublic FDA data

CUSMED FACE MASK

Primary DI
14717002404387
Brand
CUSMED FACE MASK
Company
OSSAWARE BIOTECH CO., LTD.
Model
9600.0000.00
Device description
3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use
Published
2021-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14717002404387PackageGS150Not in Commercial Distribution
24717002404384PackageGS150Not in Commercial Distribution
04717002404380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471700240438714717002404387
2471700240438424717002404384
04717002404380047170024043804717002404380

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88647977428FDA@CUSMED.COM

Regulatory Flags#

DUNS number
656747172
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04717002404328CirFIX® Cranial bone fixation system: Burr Hole Cover9905.0014.11S9905.0014.11S2020-09-28
04717002404335CirFIX® Cranial bone fixation system: Burr Hole Cover9906.0014.11S9906.0014.11S2020-09-14
04717002404168CirFIX® Cranial bone fixation system: Flap Fixator9903.0001.15S9903.0001.15S2020-09-28
04717002404175CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)9903.0101.15S9903.0101.15S2020-09-28
04717002404380CUSMED FACE MASK9600.0000.002021-03-23
14717002404165CirFIX® Cranial bone fixation system: Flap Fixator9903.0001.15S9903.0001.15S2020-09-28
14717002404172CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)9903.0101.15S9903.0101.15S2020-09-28
14717002404325CirFIX® Cranial bone fixation system: Burr Hole Cover9905.0014.11S9905.0014.11S2020-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
G3731331500Zinnanti SurgicalZinnanti Surgical Design Group IncLYU2026-06-10
00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420038American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420052American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09