ASTEC - 5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 30° Neck - ASTEC BIO USA INC

Duns Number:041434170

Device Description: 5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Spiked

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More Product Details

Catalog Number

AI4030-HL

Brand Name

ASTEC

Version/Model Number

ICSI Injection Pipette

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUC

Product Code Name

Microtools, Assisted Reproduction (Pipettes), Exempt

Device Record Status

Public Device Record Key

f239a61c-27cb-47e3-8d2a-87c53e220a92

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASTEC BIO USA INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50