FDA.reportPublic FDA data

Centrifuge Tube 50 mL

Primary DI
27350025914606
Brand
Centrifuge Tube 50 mL
Company
Hertart ApS
Model
16106
Published
2020-05-29
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
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
27350025914606PackageGS112In Commercial Distribution
17350025914609PrimaryGS10
07350025914602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2735002591460627350025914606
1735002591460917350025914609
07350025914602073500259146027350025914602

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction centrifuge tubeA sterile container (a dedicated sealable centrifuge tube) intended for the preparation, centrifuging and storage of biological samples used in assisted reproduction techniques (ART), e.g., sperm. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF). Its main application being the separation of unwanted biological material of human origin, e.g., by adding semen and a gradient to the biological material in the tube and applying centrifugation, this facilitates the removal of seminal plasma, dead sperm and other cells; spermatozoa of highest mobility can be thus selected. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305164017
Device count
15
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350025919048Micro well group culture dish, 9-well166042016-06-15
17350025919062Micro well group culture dish, 16-well166062016-06-15
17350025914562Sperm Collection Container161022021-04-30
17350025914616Pasteur Pipette 1 mL162012020-12-22
17350025914623Pasteur Pipette 3 mL162022020-12-22
07350025914541Collection Dish 90 mm160072020-05-29
07350025914558Oocyte Collection Tube 14 mL161012020-05-29
27350025914590Centrifuge Tube 15 mL161052020-05-29

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