FDA.report

Surgi-Sign

Primary DI
G047SMSRKT0
Brand
Surgi-Sign
Company
Or-6, LLC
Model
1
Catalog number
SMS-RKT
Device description
A temporary tattoo that helps healthcare providers mark and confirm the correct operative site before the procedure. For more information please visit www.surgisign.com
Published
2021-02-27
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

Related Records

Product Codes

CodeName
FZZMarker, Skin

Product Code Classifications

CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G047SMSRKT1PrimaryHIBCC0
G047SMSRKT0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Skin marking stickerA hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
033826164
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G047SMS10Surgi-Sign1SMS-12021-02-27
G047SMS20Surgi-Sign1SMS-22021-02-27
G047SMSEYE0Surgi-Sign1SMS-Eye2021-02-27
G047SMSWAND0Surgi-Sign1SMS-WAND2021-02-27

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