FDA.report

ORIGIO Gradient 100

Primary DI
60888937029361
Company
Coopersurgical, Inc.
Model
84000060M
Device description
ORIGIO Gradient 100, 60 ml
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Regulatory Flags

DUNS number
801895244
Device count
1
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
60888937029361PackageGS12In Commercial Distribution
00888937029352PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
60888937029361PackageGS1284002060M00888937029352In Commercial Distribution
00888937029352PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MQLMedia, Reproductive2Obstetrics/Gynecology884.6180NEligible

Premarket Submissions

SubmissionSupplement
K153267000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K153267000ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S2016-07-22MQL

GMDN Terms

TermDefinition
IVF mediumA solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
60888937029798ORIGIO Gradient 90 w/o Gentamicin Coopersurgical, Inc.MQL2026-03-12
00859500005325FemSperm No AnalysisFEMASYS INC.MQL2026-02-06
00859500005356FemSperm No AnalysisFEMASYS INC.MQL2026-02-06
00888937028331ORIGIO Sequential BlastCoopersurgical, Inc.MQL2026-02-05
00888937028348ORIGIO Sequential BlastCoopersurgical, Inc.MQL2026-02-05
00888937028355ORIGIO Sequential BlastCoopersurgical, Inc.MQL2026-02-05
00888937028386ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028393ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028409ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028416ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028430ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028447ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028454ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028461ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028607SynVitro FlushCoopersurgical, Inc.MQL2026-02-05
00888937028959Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937028966Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937028973Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937028980Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937029116SAGE 1-StepCoopersurgical, Inc.MQL2026-02-05
00888937029123SAGE 1-StepCoopersurgical, Inc.MQL2026-02-05
60888937029330ORIGIO Sperm WashCoopersurgical, Inc.MQL2026-02-05
00888937029383ORIGIO Gradient 90Coopersurgical, Inc.MQL2026-02-05
00888937833041SAGE 1-StepCoopersurgical, Inc.MQL2026-02-05
00888937027921SynVitro HyadaseCoopersurgical, Inc.MQL2026-02-05
00888937029970ICSI CumulaseCoopersurgical, Inc.MQL2026-02-05
60888937028203IVM SystemCoopersurgical, Inc.MQL2026-02-05
60888937029194MC Vitrification CoolingCoopersurgical, Inc.MQL2026-02-05
60888937029200MC Vitrification WarmingCoopersurgical, Inc.MQL2026-02-05
00888937030396ORIGIO Sperm WashCoopersurgical, Inc.MQL2026-02-05