ASTEC

Basic Information

• Brand Name: ASTEC
• Primary DI: B951AZ12301
• Version / Model: Zona Drilling Pipette
• Catalog Number: AZ1230
• 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: 063979a2-4763-4cb8-8dfd-a8cab10abbe6

Device Description

10-12µm ID, 30° Neck Angle, 0.55mm Tip to Elbow, Spikeless

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	B951AZ12300	HIBCC
Primary	B951AZ12301	HIBCC

Storage Conditions

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