AccessGUDID - DEVICE: ASTEC (B951AI5030YL1)

GUDID

Device Identifier (DI) Information

Brand Name: ASTEC
Version or Model: ICSI Injection Pipette
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AI5030-YL
Company Name: ASTEC BIO USA INC

Primary DI Number: B951AI5030YL1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 041434170 *Terms of Use

Device Description: 7µm OD, 5.0µm ID, 30° Tip Bevel, 30° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 16 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 830f11c3-3036-49fc-9041-ecaf178ca3f8
Public Version Date: November 20, 2020
Public Version Number: 1
DI Record Publish Date: November 12, 2020