FDA.reportPublic FDA data

N/A

Primary DI
20888937907814
Brand
N/A
Company
ORIGIO INC.
Model
MXL3-PLG
Device description
PLUNGER REPLACEMENT
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K041435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041435000THE STRIPPER PGDMid-Atlantic Diagnostics, Inc.2004-09-29MQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937907814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893790781420888937907814

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

Regulatory Flags#

DUNS number
787068394
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937907834N/AMXL3-PLG-PGD2016-08-22
00888937907872STRIPPERMXL3-STR2016-08-22
00888937907889N/AMXL3-STR-BP-DE2016-08-22
00888937907902N/AMXL3-STR-BP-SW2016-08-22
00888937907919STRIPPERMXL3-STR-CC2016-08-22
00888937907926STRIPPERMXL3-STR-CGR2016-08-22
00888937907933STRIPPERMXL3-STR-PGD2016-08-22
00888937907940STRIPPERMXL3-STR-PGD-CG2016-08-22
20888937906220STRIPPER MXL3-1002016-08-22
20888937906237STRIPPER MXL3-1252016-08-22
20888937906244STRIPPER MXL3-1352016-08-22
20888937906251STRIPPER MXL3-1502016-08-22
20888937906268STRIPPER MXL3-1752016-08-22
20888937906275STRIPPER MXL3-2002016-08-22
20888937906282STRIPPER MXL3-502016-08-22
20888937906299STRIPPER MXL3-6002016-08-22
20888937906305STRIPPER MXL3-752016-08-22
20888937906312STRIPPERMXL3-CC2016-08-22
20888937906329STRIPPERMXL3-IND-1002016-08-22
20888937906336STRIPPERMXL3-IND-1252016-08-22

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