FDA.reportPublic FDA data

16G Wallace Dual Lumen Oocyte Recovery Set

Primary DI
30888937020893
Brand
16G Wallace Dual Lumen Oocyte Recovery Set
Company
Coopersurgical, Inc.
Model
DNS1633-500
Device description
16G Wallace Dual Lumen Oocyte Recovery Set, 500 mm tubing (Box of 10)
Published
2019-12-04
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
true

Product Codes#

Code, Name table
CodeName
MQENeedle, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQENeedle, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937020896PackageGS110In Commercial Distribution
30888937020893PackageGS110In Commercial Distribution
00888937020892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893702089620888937020896
3088893702089330888937020893
00888937020892008889370208928889370208920888937020892

GMDN Terms#

Term, Definition table
TermDefinition
IVF oocyte aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter
Needle Gauge16Gauge

Sterilization Methods#

Method table
Method

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971982050298VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQE2024-12-06
06971982050304VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQE2024-12-06
06971982050311VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQE2024-12-06
17350025915477Follicle Aspiration Set Reduced Single Lumen, LuerVitrolife Sweden ABMQE2024-11-26
17350025915484Follicle Aspiration Set Reduced Single Lumen, LuerVitrolife Sweden ABMQE2024-11-26
17350025915682Follicle Aspiration Set Reduced Single LumenVitrolife Sweden ABMQE2024-07-02
17350025915699 Follicle Aspiration Set Single LumenVitrolife Sweden ABMQE2024-07-02
00841436122214Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436123051Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436123068Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436122269Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436122290Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436123099Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436122351Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
00841436123228Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
14580745043706OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
14580745043720OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
14580745043737OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
00812261016597ASPIALLWIN MEDICAL DEVICES, INC.MQE2024-01-09
03700111425804HOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cmLABORATOIRE CCDMQE2023-12-05
03700111425811HOC CLASSIC WITHOUT VALVE Aspiration tube 67 cmLABORATOIRE CCDMQE2023-12-05
03700111425828HOC2 CLASSIC WITHOUT VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05
03700111425835OPS CLASSIC WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111425842OPS CLASSIC WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111425866HOC COLLECTION VIAL 30MLLABORATOIRE CCDMQE2023-12-05
03700111425910OPS A.R.T. OF C.C.D. ® WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111425927OPS A.R.T. OF C.C.D. ®WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111425934HOC A.R.T. OF C.C.D.® WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111425941HOC A.R.T. OF C.C.D.® WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111425958HOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05