ASTEC

Basic Information

• Brand Name: ASTEC
• Primary DI: B951AH7030S1
• Version / Model: Holding Pipette
• Catalog Number: AH7030-S
• Company Name: ASTEC BIO USA INC
• Labeler DUNS: 041434170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-11-12
• Public Version: 1
• Public Version Date: 2020-11-20
• Public Version Status: New
• Public Device Record Key: 363cf0fa-9599-4e5d-8ba7-1220025bc703

Device Description

Holding Pipette, 70µm OD, 10-15µm ID, 30° Neck Angle, 0.65mm TTE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	884.6130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B951AH7030S0	HIBCC
Primary	B951AH7030S1	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 16 – 25 Degrees Celsius