Alltrista Plastics LLC

Address:20 Setar Way,Reedsville,PA,17084,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

Slides, Microscope (KEW) (5) Container, Specimen Mailer And Storage, Non-Sterile (NNK) (2) Bag, Urine Collection, Leg, For External Use, Non-Sterile (NNW) (1) Needle, Hypodermic, Single Lumen, Reprocessed (NKK) (1) Station, Pipetting And Diluting, For Clinical Use (JQW) (1)

Premarket Exempt

Yes

Clear

Kova Plastics - 00850033297003 Catalog Number : 87135 / 87135E

Device Description : Box containing 500 Kova petters (plastic pipettes for urinalysis)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : JQW

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297010 Catalog Number : 87139 / 87139E

Device Description : Box of 500 Kova Caps (Plastic caps for tubes used in urinalysis).

Device Class : 2

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : NKK

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297027 Catalog Number : 87137 / 87137E

Device Description : Box of 500 Kova Supertubes (plastic graduated sample tubes) for use in urinalysis.

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297034 Catalog Number : 87138 / 87138E

Device Description : Box of 500 Kova Econotubes (plastic graduated sample tubes) for use in urinalysis.

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297041 Catalog Number : 87144 / 87144E / 87144F

Device Description : Box of 100 Kova Slide 10s with Grid (plastic 10-chambered slides with grids for Box of 100 Kova Slide 10s with Grid (plastic 10-chambered slides with grids for urinalysis)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297058 Catalog Number : 87146 / 87146E

Device Description : Box of 100 Slide 10s (plastic 10-chambered slides without grids for urinalysis)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297065 Catalog Number : 87100 / 87100E

Device Description : Box containing 100 Kova Slide II with grids (plastic 4-chambered microscope slid Box containing 100 Kova Slide II with grids (plastic 4-chambered microscope slides with gridlines for urinalysis)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297072 Catalog Number : 87118 / 87118E

Device Description : Box containing 100 Kova Slide IIs without grids (plastic 4-chambered microscope Box containing 100 Kova Slide IIs without grids (plastic 4-chambered microscope slide without gridlines for urinalysis)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297089 Catalog Number : 87162 / 87162E

Device Description : Kova Plastics Super System Pac 1000 with Grid (Urinalysis package containing 100 Kova Plastics Super System Pac 1000 with Grid (Urinalysis package containing 1000 plastic tubes, 1000 plastic pipettes, and 100 10-chambered microscope slides with gridlines)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : NNW

Prescription Use : No

Device Count : 1

Kova Plastics - 00850033297096 Catalog Number : 87157 / 87157E

Device Description : Box of 50 Kova Slide 10s (plastic 10-chambered gridless slides for urinalysis)

Device Class : 1

Duns Number: 197201572

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

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