FDA.reportPublic FDA data

MICROTOOLS (Denuding Pipette)

Primary DI
07540268000372
Brand
MICROTOOLS (Denuding Pipette)
Company
Arsci Inc.
Model
D-150
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 Denuding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, for the removal or separation of cumulus cells from the oocyte. The Denuding Pipette is also used for transferring oocytes, blastomeres, and embryos. Intended for one-time use.
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQHMicrotools, Assisted Reproduction (Pipettes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQHMicrotools, Assisted Reproduction (Pipettes)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102480000INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.2011-04-19MQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540268000372PrimaryGS10
07540268000044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540268000372075402680003727540268000372
07540268000044075402680000447540268000044

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction microtoolA 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.

Contacts#

Phone, Email table
PhoneEmail
450-674-6886raina@arsci.ca

Regulatory Flags#

DUNS number
241975256
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540268000006MICROTOOLS (Injection Pipiette)I-00012022-10-07
07540268000013MICROTOOLS (Injection Pipiette)I-30012022-10-07
07540268000037MICROTOOLS (Injection Pipiette)I-35012022-10-07
07540268000051MICROTOOLS (Injection Pipiette)PIEZO-30012022-10-07
07540268000075MICROTOOLS (Injection Pipiette)I-30NP2022-10-07
07540268000099MICROTOOLS (Injection Pipiette)I-35NP2022-10-07
07540268000112MICROTOOLS (Injection Pipiette)PIEZO-35012022-10-07
07540268000136MICROTOOLS (Holding Pipette)H-30012022-10-07
07540268000174MICROTOOLS (Holding Pipette)H-35012022-10-07
07540268000198MICROTOOLS (Holding Pipette)H-30022022-10-07
07540268000211MICROTOOLS (Holding Pipette)H-30032022-10-07
07540268000235MICROTOOLS (Holding Pipette)H-35032022-10-07
07540268000259MICROTOOLS (Holding Pipette)H-35022022-10-07
07540268000280MICROTOOLS (Denuding Pipette)D-1202022-10-07
07540268000310MICROTOOLS (Denuding Pipette)D-1302022-10-07
07540268000341MICROTOOLS (Denuding Pipette)D-1402022-10-07
07540268000402MICROTOOLS (Denuding Pipette)D-1602022-10-07
07540268000433MICROTOOLS (Denuding Pipette)D-1702022-10-07
07540268000464MICROTOOLS (Denuding Pipette)D-1802022-10-07
07540268000495MICROTOOLS (Denuding Pipette)D-1902022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060488046858EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046865EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046872EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046889EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046896EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046902EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046919EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046926EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046933EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046940EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046957EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046964EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046971EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046988EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046995EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047008EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047015EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047022EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047039EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047046EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047053EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047060EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047077EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047084EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047091EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047107EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047114EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047121EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047138EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047145EZ-TipCoopersurgical, Inc.MQH2025-04-11