PROPPER MANUFACTURING COMPANY, INC.

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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

Wrap, Sterilization (FRG) (8) Indicator, Physical/Chemical Sterilization Process (JOJ) (1) Tourniquet, Nonpneumatic (GAX) (1)

Premarket Exempt

Yes No

Clear

Propper Chex-All Sterilization Pouches - 10818087010136 Catalog Number : 02431400

Device Description : Chex-All® II Instant-Seal Pouches - 9 x 16" - Steam or EO - 1 Case of 500

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010143 Catalog Number : 02431800

Device Description : Chex-All® II Instant-Seal Pouches - 13 x 18" - Steam or EO - 1 Case of 500

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010150 Catalog Number : 02500800

Device Description : Chex-All® Sterilization Pouches - 3 x 8" - Steam or EO - 1 Case of 1000

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010167 Catalog Number : 02501000

Device Description : Chex-All® Sterilization Pouches - 5 x 10" - Steam or EO - 1 Case of 1000

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010174 Catalog Number : 02501200

Device Description : Chex-All® Sterilization Pouches - 7 x 12" - Steam or EO - 1 Case of 1000

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010181 Catalog Number : 02501400

Device Description : Chex-All® Sterilization Pouches - 8 x 16" - Steam or EO - 1 Case of 500

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010198 Catalog Number : 02501800

Device Description : Chex-All® Sterilization Pouches - 12x 18" - Steam or EO - 1 Case of 500

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Chex-All Sterilization Pouches - 10818087010204 Catalog Number : 02502400

Device Description : Chex-All® Sterilization Pouches - 18 x 24" - Steam or EO - 1 Case of 500

Device Class :

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Propper Velket Tourniquet - 10818087011652 Catalog Number : 22101100

Device Description : Velket - Single, Adult Size, Universal

Device Class : 1

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

Propper Strate-Line Autoclave Indicator Tape - 10818087011874 Catalog Number : 26812400

Device Description : Strate-Line Autoclave Indicator Tape - 1/2" x 60yds - 1 Roll

Device Class : 2

Duns Number: 001483130

Premarket Exempt : Yes

Product Code : JOJ

Prescription Use : No

Device Count : 1

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