ASTEC BIO USA INC

Address:10 Keith Way,Hingham,MA,02043,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

Microtools, Assisted Reproduction (Pipettes), Exempt (PUC) (10)

Premarket Exempt

Yes

Clear

ASTEC - B951AI4530HL1 Catalog Number : AI4530-HL

Device Description : 5.5-6µm OD, 4.5µm ID, 30° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI4530V1 Catalog Number : AI4530-V

Device Description : 5.5-6µm OD, 4.5µm ID, 30° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI4530VL1 Catalog Number : AI4530-VL

Device Description : 6µm OD, 4.5µm ID, 30° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI4530W1 Catalog Number : AI4530-W

Device Description : 5.5-6µm OD, 4.5µm ID, 30° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI4530YL1 Catalog Number : AI4530-YL

Device Description : 6µm OD, 4.5µm ID, 30° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI4535V1 Catalog Number : AI4535-V

Device Description : 6µm OD, 4.5µm ID, 30° Tip Bevel, 35° Neck Angle, 0.55mm Tip to Elbow, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI5020FR1 Catalog Number : AI5020-FR

Device Description : 7µm OD, 5.0µm ID, 30° Tip Bevel, 20° Neck Angle, 2mm Tip to Elbow, Spikeless for 7µm OD, 5.0µm ID, 30° Tip Bevel, 20° Neck Angle, 2mm Tip to Elbow, Spikeless for Piezo ICSI

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI5020V1 Catalog Number : AI5020-V

Device Description : 7µm OD, 5.0µm ID, 30° Tip Bevel, 20° Neck Angle, 0.55mm Tip to Elbow, Spiked

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI5025FR1 Catalog Number : AI5025-FR

Device Description : 7µm OD, 5.0µm ID, 30° Tip Bevel, 25° Neck Angle, 2mm Tip to Elbow, Spikeless for 7µm OD, 5.0µm ID, 30° Tip Bevel, 25° Neck Angle, 2mm Tip to Elbow, Spikeless for Piezo ICSI

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

ASTEC - B951AI5030FR1 Catalog Number : AI5030-FR

Device Description : 7µm OD, 5.0µm ID, 30° Tip Bevel, 30° Neck Angle, 2mm Tip to Elbow, Spikeless for 7µm OD, 5.0µm ID, 30° Tip Bevel, 30° Neck Angle, 2mm Tip to Elbow, Spikeless for Piezo ICSI

Device Class : 2

Duns Number: 041434170

Premarket Exempt : Yes

Product Code : PUC

Prescription Use : Yes

Device Count : 10

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