Or-6, LLC

Address:100 Independence Drive,Hyannis,MA,02601,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Marker, Skin (FZZ) (5)

Premarket Exempt

Yes

Clear

Surgi-Sign - G047SMS11 Catalog Number : SMS-1

Device Description : A temporary tattoo that helps healthcare providers mark and confirm the correct

Device Class : 1

Duns Number: 033826164

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 50

Surgi-Sign - G047SMS21 Catalog Number : SMS-2

Device Description : A temporary tattoo that helps healthcare providers mark and confirm the correct

Device Class : 1

Duns Number: 033826164

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 50

Surgi-Sign - G047SMSEYE1 Catalog Number : SMS-Eye

Device Description : A temporary tattoo that helps healthcare providers mark and confirm the correct

Device Class : 1

Duns Number: 033826164

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 50

Surgi-Sign - G047SMSRKT1 Catalog Number : SMS-RKT

Device Description : A temporary tattoo that helps healthcare providers mark and confirm the correct

Device Class : 1

Duns Number: 033826164

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 50

Surgi-Sign - G047SMSWAND1 Catalog Number : SMS-WAND

Device Description : A temporary tattoo that helps healthcare providers mark and confirm the correct

Device Class : 1

Duns Number: 033826164

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : No

Device Count : 50

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