AccessGUDID - DEVICE: MICROTOOLS (Transfer Pipette) (07540268000877)

GUDID

Device Identifier (DI) Information

Brand Name: MICROTOOLS (Transfer Pipette)
Version or Model: TP-1200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Arsci Inc.

Primary DI Number: 07540268000877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 241975256 *Terms of Use

Device Description: A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Transfer Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to separate cumulus-oocyte complexes (COCs) into washing or culture dishes after oocyte collection. The Transfer Pipette is also used for transferring COCs into hyaluronidase solution to denude cumulus cells from oocytes. Intended for one-time use.

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):	No
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
MQH	Microtools, Assisted Reproduction (Pipettes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102480	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb003a5f-3463-4151-b611-3f1a10751f38
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022