ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Address:11811 Landon Drive, Suite 300,Mira Loma,CA,91752,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

Sterilizer, chemical (MLR) (8) Indicator, physical/chemical sterilization process (JOJ) (2) Sterilizer, ethylene-oxide gas (FLF) (2) Wrap, sterilization (FRG) (2)

Premarket Exempt

No Yes

Clear

Sterrad - 10705037014491 Catalog Number : 10104

Device Description : Sterrad 100 NX Sterilizer

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

Sterrad - 10705037014507 Catalog Number : 10104-002

Device Description : Sterrad 100 NX 2-DR

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

Sterrad - 10705037014583 Catalog Number : 10113

Device Description : Sterrad 100s Cassette

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR, FLF

Prescription Use : No

Device Count : 1

Sterrad - 10705037014651 Catalog Number : 10118

Device Description : Sterrad 200 Cassette

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : FLF, MLR

Prescription Use : No

Device Count : 1

Sterrad - 10705037014835 Catalog Number : 10133

Device Description : Sterrad NX Cassette

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

Sterrad - 10705037014903 Catalog Number : 10144

Device Description : Sterrad 100 NX Cassette

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

Sterrad - 10705037015184 Catalog Number : 10207

Device Description : Shelf Sterrad 200 2-Tier

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

Sterrad - 10705037015191 Catalog Number : 10208

Device Description : Carriage Sterrad 200 4 Wheels

Device Class : 2

Duns Number: 947451626

Premarket Exempt : No

Product Code : MLR

Prescription Use : No

Device Count : 1

Tyvek Self Seal Pouch - 10705037015719 Catalog Number : 12320

Device Description : Tyvek Self Seal Pouch with Sterrad Chemical Indicator 75 mm x 200 mm

Device Class :

Duns Number: 947451626

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 250

Tyvek Self Seal Pouch - 10705037015726 Catalog Number : 12326

Device Description : Tyvek Self Seal Pouch with Sterrad Chemical Indicator 100 mm x 260 mm

Device Class :

Duns Number: 947451626

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 250

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