FDA.reportPublic FDA data

ROLLED GAUZE

Primary DI
M68933300050
Brand
ROLLED GAUZE
Company
Safeguard US Operating, LLC
Model
05
Catalog number
33-300
Device description
"ROLLED GAUZE1 ea - 4.1 yds x 4.5"", six-ply, sterile gauze"
Published
2018-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
M68933300050PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Kit
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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D832SAPR31PlasdentPLASDENT CORPORATIONNAB2026-10-13
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