FDA.reportPublic FDA data

16G Wallace Single Lumen Oocyte Recovery Set

Primary DI
00888937020953
Brand
16G Wallace Single Lumen Oocyte Recovery Set
Company
Coopersurgical, Inc.
Model
ONS1633LL
Device description
16G Wallace Single Lumen Oocyte Recovery Set, 950 mm tubing, flushing connector (Box of 10)
Published
2019-12-04
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

Product Codes#

Code, Name table
CodeName
KOCAccessories, Blood Circuit, Hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937020957PackageGS110In Commercial Distribution
30888937020954PackageGS110In Commercial Distribution
00888937020953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893702095720888937020957
3088893702095430888937020954
00888937020953008889370209538889370209530888937020953

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
Length950Millimeter
Needle Gauge16Gauge

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289103689System One Cycler BaseNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103696Extended Cycler Base and Filter HolderNXSTAGE MEDICAL, INC.KOC2026-04-22
00842289103702Fluid Detection SystemNXSTAGE MEDICAL, INC.KOC2026-04-22
04987671100627Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
24987671100621Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
04987671100658Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023625008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023795008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023865008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611024615008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
04987671400000Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2023-08-28
B144MPC825S0Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
B144MPC825S1Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
00840861102259CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
00840861102266CombiSet SMARTECHFresenius Medical Care Renal Therapies Group, LLCKOC2020-11-17
04987671201102BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
24987671201106BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
00842289102613Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
10842289102610Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
00865165000209HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000216HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-12
00865165000223HemoBandINNOVATIONS FOR ACCESS INCKOC2020-09-03
0088893702096016G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702099117G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702100417G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04
0088893702101118G Wallace Single Lumen Oocyte Recovery SetCoopersurgical, Inc.KOC2019-12-04