FDA.reportPublic FDA data

SteriTatt Original Black Cartridge

Primary DI
00843696195007
Brand
SteriTatt Original Black Cartridge
Company
Flow X Ray Corporation
Model
90001
Published
2020-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843696195007PrimaryGS10
30843696195008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696195007008436961950078436961950070843696195007
3084369619500830843696195008

GMDN Terms#

Term, Definition table
TermDefinition
Tattoo ink, dermalA sterile, synthetic, implantable dye solution intended to be injected between the layers of the skin, using a tattoo needle and hand-held ink injector, for aesthetic pigmentation of the skin and visible mucous membranes. It is typically pH balanced for dermal applications and does not contain animal-derived materials. It may be implanted for a variety of reasons (e.g., for cosmetic decoration, to replace colour in the skin for patients affected by pigment deficiencies, for radiotherapy marking).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010016319
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843696114312COMPRESSION PADDLE141072022-12-22
00081204503900DV-58 ADULT ECONO PAK182042023-08-09
00812045030115DX-58 ADULT PAPER PAK180012023-08-09
00812045030634DX-42 BITE CHEX180602023-08-09
00812045030832DV-57 ADULT TWIN VALUE PAK18201E2023-08-09
00812045030849DV-53 CHILD TWIN PEDO PAK18236E2023-08-09
00812045030856DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET19235E2023-08-09
00812045030863DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET19601E2023-08-09
00812045030870" DUPLICATING FILM, 14 X 17"""311762023-08-09
00812045030887DV-58 ADULT VALUE PAK182002023-08-09
00812045030894DV-57 ADULT TWIN VALUE PAK182012023-08-09
00812045030917DV-54 CHILD ECONO PAK182062023-08-09
00812045030924FV-58 ADULT ECONO PAK182152023-08-09
00812045030931DV-54 CHILD PEDO PAK182352023-08-09
00812045030948DV-53 CHILD TWIN PEDO PAK182362023-08-09
00812045030955FV-58 ADULT VALUE PAK183102023-08-09
00812045030962FV-57 ADULT TWIN VALUE PAK184102023-08-09
00812045030979DV-58 ADULT FRESH PAK186002023-08-09
00812045030986DV-57 ADULT TWIN FRESH PAK186012023-08-09
00812045030993FV-58 ADULT FRESH PAK186202023-08-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630094177274Bioseal Inc.BIOSEALFZZ2023-10-03
10884389289280Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FZZ2023-10-01
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