AMD Medicom Inc

Address:6054 Shook Road,Lockbourne,OH,43137,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

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (6) Mask, Surgical (FXX) (4)

Premarket Exempt

Yes No

Clear

Hedy SoftMask - D903420LFG1 Catalog Number : 420LFG

Device Description : Procedure Mask

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Hedy SoftMask - D903420LFP1 Catalog Number : 420LFP

Device Description : Procedure Mask

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Hedy SoftMask - D903420LFW1 Catalog Number : 420LFW

Device Description : Procedure Mask

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Hedy SoftMask - D903430HVB1 Catalog Number : 430HVB

Device Description : Procedure Mask

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

HedySeal Max Self-Sealing Sterilization Pouch - D903610HSM40 Catalog Number : 610HSM-40

Device Description : HedySeal Max Pouches 3.5"x9" with Class 4 indicator detachable strips

Device Class :

Duns Number: 256880576

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HedySeal PRO Self-Sealing Sterilization Pouches - D903610HSP10 Catalog Number : 610HSP-10

Device Description : HedySeal Pro Pouches 2.25"x4" with Class 4 Indicators

Device Class : 2

Duns Number: 256880576

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HedySeal PRO Self-Sealing Sterilization Pouches - D903610HSP20 Catalog Number : 610HSP-20

Device Description : HedySeal Pro Pouches 2.75"x9" with Class 4 Indicators

Device Class : 2

Duns Number: 256880576

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HedySeal PRO Self-Sealing Sterilization Pouches - D903610HSP30 Catalog Number : 610HSP-30

Device Description : HedySeal Pro Pouches 3.5"x5.25" with Class 4 Indicators

Device Class : 2

Duns Number: 256880576

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HedySeal PRO Self-Sealing Sterilization Pouches - D903610HSP40 Catalog Number : 610HSP-40

Device Description : HedySeal Pro Pouches 3.5"x9" with Class 4 Indicators

Device Class : 2

Duns Number: 256880576

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HedySeal PRO Self-Sealing Sterilization Pouches - D903610HSP50 Catalog Number : 610HSP-50

Device Description : HedySeal Pro Pouches 5.25"x10" with Class 4 Indicators

Device Class : 2

Duns Number: 256880576

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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