UNIPACK MEDICAL CORPORATION

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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) (9) CHAIR, DENTAL, WITHOUT OPERATIVE UNIT (NRU) (1)

Premarket Exempt

No Yes

Clear

Unipack - D784UBC8123R1 Catalog Number : UBC-8123-R

Device Description : Half Chair Sleeves 27 1/2 " x 24" Roll

Device Class : 1

Duns Number: 018319397

Premarket Exempt : Yes

Product Code : NRU

Prescription Use : No

Device Count : 225

Unipack - D784UPP10151 Catalog Number : UPP-1015

Device Description : Sterilization Pouches 10" x 15"

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

Unipack Sterilization Wrap - D784UPP12121 Catalog Number : UPP-1212

Device Description : 12" x 12" - Sterilization Wrap for Steam / ETO / Gamma

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 100

Unipack - D784UPP12181 Catalog Number : UPP-1218

Device Description : Sterilization Pouches 12" x 18"

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

Unipack Sterilization Wrap - D784UPP15151 Catalog Number : UPP-1515

Device Description : 15" x 15" - Sterilization Wrap for Steam / ETO / Gamma

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 100

Unipack Sterilization Wrap - D784UPP20201 Catalog Number : UPP-2020

Device Description : 20" x 20" - Sterilization Wrap for Steam / ETO / Gamma

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 100

Unipack - D784UPP2231 Catalog Number : UPP-223

Device Description : Sterilization Pouches 2-1/4" x 3-3/4"

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

Unipack - D784UPP2251 Catalog Number : UPP-225

Device Description : Sterilization Pouches 2-1/4" x 5"

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

Unipack Sterilization Wrap - D784UPP24241 Catalog Number : UPP-2424

Device Description : 24" x 24" - Sterilization Wrap for Steam / ETO / Gamma

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 100

Unipack - D784UPP27101 Catalog Number : UPP-2710

Device Description : Sterilization Pouches 2-3/4" x10"

Device Class :

Duns Number: 018319397

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

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