FDA.reportPublic FDA data

SteriTatt

Primary DI
00843696195014
Brand
SteriTatt
Company
FLOW X RAY CORPORATION
Model
90002
Device description
25 Single Service SteriTatt Markers and 25 sterile needles
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FZZMarker, Skin

Product Code Classifications

CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843696195014PrimaryGS10
30843696195015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843696195014008436961950148436961950140843696195014
3084369619501530843696195015

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
010016319
Device count
25
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
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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