FDA.reportPublic FDA data

ATOMO

Primary DI
D883AA00301
Brand
ATOMO
Company
ATOMO DENTAL, INC.
Model
AA0030
Device description
"ATOMO Non-woven sponge 2""x2"""
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D883AA00303PackageHIBCC25In Commercial Distribution
D883AA00301PrimaryHIBCC0
D883AA00300Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Saliva absorbentA non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.

Regulatory Flags#

DUNS number
088480717
Device count
200
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D883AA02101ATOMOAA02102022-09-09
D883AA02111ATOMOAA02112022-09-09
D883AA02201ATOMOAA02202022-09-08
D883AA02381ATOMOAA02382022-09-08
D883AA02391ATOMOAA02392022-09-08
D883AA02501ATOMOAA02502022-09-06
D883AA02601ATOMOAA02602022-09-08
D883AA02611ATOMOAA02612022-09-08
D883AA02621ATOMOAA02622022-09-09
D883AA02701ATOMOAA02702022-09-08
D883AA02711ATOMOAA02712022-09-08
D883AA02811ATOMOAA02812022-09-08
D883AA02821ATOMOAA02822022-09-08
D883AA08811ATOMOAA08812022-09-09
D883AA08831ATOMOAA08832022-09-09
D883AA08841ATOMOAA08842022-09-09
D883AA12401ATOMOAA12402022-09-05
D883AA12421ATOMOAA12422022-09-05
D883AA12431ATOMOAA12432022-09-05
D883AA12461ATOMOAA12462022-09-05

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