FDA.reportPublic FDA data

MICROTOOLS (Assisted Hatching Pipette)

Primary DI
07540268000020
Brand
MICROTOOLS (Assisted Hatching Pipette)
Company
Arsci Inc.
Model
AH-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 Assisted Hatching Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to puncture a hole in the zona pellucida to enable embryo assisted hatching using Tyrode’s acid solution. 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
Rx
false
OTC
false
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
07540268000006PrimaryGS10
07540268000013PrimaryGS10
07540268000037PrimaryGS10
07540268000051PrimaryGS10
07540268000075PrimaryGS10
07540268000099PrimaryGS10
07540268000112PrimaryGS10
07540268000136PrimaryGS10
07540268000174PrimaryGS10
07540268000198PrimaryGS10
07540268000211PrimaryGS10
07540268000235PrimaryGS10
07540268000259PrimaryGS10
07540268000570PrimaryGS10
07540268000587PrimaryGS10
07540268000594PrimaryGS10
07540268000600PrimaryGS10
07540268000617PrimaryGS10
07540268000624PrimaryGS10
07540268000631PrimaryGS10
07540268000648PrimaryGS10
07540268000655PrimaryGS10
07540268000662PrimaryGS10
07540268000679PrimaryGS10
07540268000686PrimaryGS10
07540268000693PrimaryGS10
07540268000709PrimaryGS10
07540268000716PrimaryGS10
07540268000723PrimaryGS10
07540268000754PrimaryGS10
07540268000778PrimaryGS10
07540268000815PrimaryGS10
07540268000839PrimaryGS10
07540268000020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540268000006075402680000067540268000006
07540268000013075402680000137540268000013
07540268000037075402680000377540268000037
07540268000051075402680000517540268000051
07540268000075075402680000757540268000075
07540268000099075402680000997540268000099
07540268000112075402680001127540268000112
07540268000136075402680001367540268000136
07540268000174075402680001747540268000174
07540268000198075402680001987540268000198
07540268000211075402680002117540268000211
07540268000235075402680002357540268000235
07540268000259075402680002597540268000259
07540268000570075402680005707540268000570
07540268000587075402680005877540268000587
07540268000594075402680005947540268000594
07540268000600075402680006007540268000600
07540268000617075402680006177540268000617
07540268000624075402680006247540268000624
07540268000631075402680006317540268000631
07540268000648075402680006487540268000648
07540268000655075402680006557540268000655
07540268000662075402680006627540268000662
07540268000679075402680006797540268000679
07540268000686075402680006867540268000686
07540268000693075402680006937540268000693
07540268000709075402680007097540268000709
07540268000716075402680007167540268000716
07540268000723075402680007237540268000723
07540268000754075402680007547540268000754
07540268000778075402680007787540268000778
07540268000815075402680008157540268000815
07540268000839075402680008397540268000839
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
241975256
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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