FDA.reportPublic FDA data

NUNC IVF MULTIDISH 4 WELL NUNCLON

Primary DI
15713311000127
Brand
NUNC IVF MULTIDISH 4 WELL NUNCLON
Company
Nunc A/S
Model
144444
Device description
NUNC IVF MULTIDISH 4 WELL NUNCLON
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
PUDLabware, Assisted Reproduction, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUDLabware, Assisted Reproduction, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35713311000121PackageGS130In Commercial Distribution
15713311000127PrimaryGS10
85713311000126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3571331100012135713311000121
1571331100012715713311000127
8571331100012685713311000126

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
305971764
Device count
4
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15713311000073110X16 U CENT.TUBE SCREWCAP PS/PE SI3482242018-08-17
15713311000097UNIVERSALCONT.25ML CAP,SPOON LABEL SI3605852018-08-17
15713311000110UNIVERSALCONT.25ML W/SCREW &LABEL SI3642462018-08-17
15713311000219CryoTube 1,8 ml SI Internal thread Starfoot Round3686322023-06-19
25713311000223CryoTube 1,8 ml SI Internal thread Starfoot Round3686322023-06-19
15713311000103UNIVERSALCONT.25ML W/SCREW CAP SI3642382018-08-17
15713311000202CryoTube 1,8 ml SI Internal thread Starfoot Round3772672023-02-17
25713311000209CryoTube 1,8 ml SI Internal thread Starfoot Round3772672023-02-17
15713311000134NUNC IVF DISH 35mmNON-TREATED1502552018-09-21
15713311000141NUNC IVF DISH 60mmNON-TREATED1502702018-09-21
15713311000158NUNC IVF DISH 90mmNON-TREATED1503602018-09-21
15713311000165NUNC IVF MULTIDISH4 WELL NON-TREATED1798302018-09-21
05713311000014NUNC IVF MULTIDISH 4 WELL NUNCLON1444441444442016-09-01
0571331100002160X15 IVF PETRID NONTREATED VENTS1502701502702016-09-01
05713311000038IVF 4 WELL DISH NONTREATED1798301798302016-09-01
0571331100004535X10 IVF PETRIDISH NONTREATED VENTS1502551502552016-09-01
0571331100005290X17 IVF PETRIDISH NONTREATED VENTS1503601503602016-09-01
15713311000233CryoTube 1,8 ml SI Internal thread Round3634012022-11-18
15713311000240CryoTube 1,0 ml SI, Internal thread, Conical3666562022-11-18
15713311000257CryoTube 1,0 ml SI, Internal Thread, Green band3777382022-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850068289445SFG 35mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289452SFG 60mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289469SFG 100mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289476SFG ICSI dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289483SFG Center well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289490SFG 4 well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289506SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289513SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289520SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
10850068289537SFG Sperm Collection ContainerSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289448SFG 35mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289455SFG 60mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289462SFG 100mm culture dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289479SFG ICSI dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289486SFG Center well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289493SFG 4 well dishSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289509SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289516SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289523SFG Sperm CDSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
00850068289530SFG Sperm Collection ContainerSPECTRUM FERTILITY GROUP INC.PUD2024-11-12
14580647510054ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
14580647510061ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
14580647510078ASTEC IVF Center Well DishASTEC CO.,LTD.PUD2024-08-01
14580647510085ASTEC IVF ICSI DishASTEC CO.,LTD.PUD2024-08-01
14580647510092ASTEC IVF 35mm Culture DishASTEC CO.,LTD.PUD2024-08-01
14580647510108ASTEC IVF 60mm Culture DishASTEC CO.,LTD.PUD2024-08-01
24580647510051ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
24580647510068ASTEC IVF 4Well DishASTEC CO.,LTD.PUD2024-08-01
24580647510075ASTEC IVF Center Well DishASTEC CO.,LTD.PUD2024-08-01
24580647510082ASTEC IVF ICSI DishASTEC CO.,LTD.PUD2024-08-01