FDA.reportPublic FDA data

NUNC IVF DISH 60mmNON-TREATED

Primary DI
35713311000145
Brand
NUNC IVF DISH 60mmNON-TREATED
Company
Nunc A/S
Model
150270
Device description
NUNC IVF DISH 60mmNON-TREATED
Published
2018-09-21
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

Product Codes#

Code, Name table
CodeName
MQKLABWARE, ASSISTED REPRODUCTION
PUDLabware, Assisted Reproduction, Exempt

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070047000NUNC IVF DISHES AND NUNC IVF 4-WELL DISHNunc A/S2007-05-18MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35713311000145PackageGS140In Commercial Distribution
15713311000141PrimaryGS10
85713311000140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3571331100014535713311000145
1571331100014115713311000141
8571331100014085713311000140

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction procedure dishA sterile container intended 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. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and 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
10
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
15713311000127NUNC IVF MULTIDISH 4 WELL NUNCLON1444442018-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888937029079LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029093LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029109LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
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06971855770322Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770339Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
00888937027952ZyMotCoopersurgical, Inc.MQK2026-01-23
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20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
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