FDA.reportPublic FDA data

RI Pipettes

Primary DI
05060488041594
Brand
RI Pipettes
Company
RESEARCH INSTRUMENTS LIMITED
Model
ICSI-Plus Non-Spiked Injection
Catalog number
7-71-5NI35L/20
Device description
Assisted Reproduction Microtools (Pipettes)
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K991261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991261000ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPETResearch Instruments , Ltd.1999-08-05MQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488041594PrimaryGS10
05060170182383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488041594050604880415945060488041594
05060170182383050601701823835060170182383

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter5Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep away from direct sunlight (UV)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4546790202origio@origio.com

Regulatory Flags#

DUNS number
536139413
Device count
20
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060170181454EZ-Tip125 micron tip id7-72-2125/52017-12-22
05060170181461EZ-Tip135 micron tip id7-72-2135/52017-12-22
05060170181478EZ-Tip145 micron tip id7-72-2145/52017-12-22
05060170181485EZ-Tip155 micron tip id7-72-2155/52017-12-22
05060170181492EZ-Tip170 micron tip id7-72-2170/52017-12-22
05060170181508EZ-Tip200 micron tip id7-72-2200/52017-12-22
05060170181515EZ-Tip290 micron tip id7-72-2290/52017-12-22
05060170181522EZ-Tip600 micron tip id7-72-2600/52017-12-22
05060170181539EZ-Tip125 micron tip id7-72-4125/202017-12-22
05060170181546EZ-Tip135 micron tip id7-72-4135/202017-12-22
05060170181553EZ-Tip145 micron tip id7-72-4145/202017-12-22
05060170181560EZ-Tip155 micron tip id7-72-4155/202017-12-22
05060170181577EZ-Tip170 micron tip id7-72-4170/202017-12-22
05060170181591EZ-Tip200 micron tip id7-72-4200/202017-12-22
05060170181607EZ-Tip290 micron tip id7-72-4290/202017-12-22
05060170181614EZ-Tip600 micron tip id7-72-4600/202017-12-22
05060170181690EZ-GripEZ-Grip7-72-28002017-12-22
05060170183328EZ-Tip75 micron tip id7-72-2075/52017-12-22
05060170183380EZ-GripEZ-Grip with Comfort Rest7-72-28022017-12-22
05060170183441EZ-Tip75 micron tip id7-72-4075/202017-12-22

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