FDA.reportPublic FDA data

ATOMO

Primary DI
D883AA00323
Brand
ATOMO
Company
ATOMO DENTAL, INC.
Model
AA0032
Device description
ATOMO Non-woven sponge 4"x4"
Published
2022-09-09
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

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
D883AA00323PackageHIBCC10In Commercial Distribution
D883AA00321PrimaryHIBCC0
D883AA00320Unit 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088480717
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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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