ORIGEN BIOMEDICAL, INC.

Address:7000 Burleson Rd. Bldg D,Austin,TX,78744,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

Container, Frozen Donor Tissue Storage (LPZ) (6) Tube, Tissue Culture (KJG) (4)

Premarket Exempt

No Yes

Clear

Injection Spike - 10816203020106 Catalog Number :

Device Description : DMSO-Resistant Bag Spike with needle injection port, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Injection Spike - 10816203020113 Catalog Number :

Device Description : DMSO-Resistant Bag Spike with non- ahdered needle injection port, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Needle-Free Valves - 10816203020120 Catalog Number :

Device Description : Needle-free valve with caps, case of 10

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203020137 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 7ml

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203020144 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 120ml

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203020151 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 240ml

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203020168 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 30ml

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203020175 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 325ml

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203020182 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 70ml

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

3ml Syringe, FLL X SCD - 10816203020199 Catalog Number :

Device Description : 3ml syringe on a female luer with 15cm sealed SCD tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

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