FDA.reportPublic FDA data

MICROTOOLS (Injection Pipiette)

Primary DI
07540268000037
Brand
MICROTOOLS (Injection Pipiette)
Company
Arsci Inc.
Model
I-3501
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 Injection Pipette (or ICSI pipette) is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to inject a single sperm directly into an oocyte to fertilize it—commonly known as the intracytoplasmic sperm injection (ICSI) of oocytes. 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
07540268000037PrimaryGS10
07540268000020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540268000037075402680000377540268000037
07540268000020075402680000207540268000020

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
10
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
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
07540268000372MICROTOOLS (Denuding Pipette)D-1502022-10-07
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