FDA.reportPublic FDA data

FareTec Compressed Gauze

Primary DI
B54122230400
Brand
FareTec Compressed Gauze
Company
FARETEC, INC.
Model
Compressed Gauze
Catalog number
2223040
Device description
"Compressed Gauze, 4.5""x4.1 yards stretched. (11.43 cm x 3.75 meters) 6 ply cotton, white."
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B54122230400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll, sterileA sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4403509510colleen@faretec.com

Regulatory Flags#

DUNS number
626802540
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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B54133311320IFAKIFAK Kit Advanced33311322024-06-14
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B54133311300IFAKUN IFAK Advanced33311302024-05-09
B54180030080Pelvic BinderPelvic Binder, Coyote Brown80030082024-02-28
B54133311280IFAKIFAK 4333311282024-01-26
B54133311250IFAKIFAK 4033311252023-12-20
B54133311260IFAKIFAK 4133311262023-12-20
B54133311270IFAKIFAK 4233311272023-12-20

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