FDA.reportPublic FDA data

MICROTOOLS (Denuding Pipette)

Primary DI
07540268000044
Brand
MICROTOOLS (Denuding Pipette)
Company
Arsci Inc.
Model
D-250
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
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
07540268000280PrimaryGS10
07540268000310PrimaryGS10
07540268000341PrimaryGS10
07540268000372PrimaryGS10
07540268000402PrimaryGS10
07540268000433PrimaryGS10
07540268000464PrimaryGS10
07540268000495PrimaryGS10
07540268000525PrimaryGS10
07540268000549PrimaryGS10
07540268000556PrimaryGS10
07540268000044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540268000280075402680002807540268000280
07540268000310075402680003107540268000310
07540268000341075402680003417540268000341
07540268000372075402680003727540268000372
07540268000402075402680004027540268000402
07540268000433075402680004337540268000433
07540268000464075402680004647540268000464
07540268000495075402680004957540268000495
07540268000525075402680005257540268000525
07540268000549075402680005497540268000549
07540268000556075402680005567540268000556
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
241975256
Device count
50
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