FDA.reportPublic FDA data

V-SPERM MORPHO SLIDE

Primary DI
04260531790641
Brand
V-SPERM MORPHO SLIDE
Company
VITROMED GmbH
Model
V-SMS-01
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04260531790641PrimaryGS10
04260531792591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260531790641042605317906414260531790641
04260531792591042605317925914260531792591

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
342250668
Device count
10
Premarket exempt
true
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
04260650070181V-GRAD 80 (2x for V-GRAD Kit)V-GRD83_12G2025-07-03
04260650070082V-GRAD 40 (2x for V-GRAD Kit)V-GRD43_12G2025-07-03
04260650070280V-GRAD 80 (2x for V-GRAD Kit)V-GRD83_12G2025-07-03
04260650070303V-GRAD 40V-GRD43_100P2025-07-03
04260650071102V-GRAD 80V-GRD83_100P2025-07-03
04260650071201V-GRAD 100V-GRD00_100P2025-07-03
04260531790009V-DENUPETV-DENUPET 125V-DEN-1252022-03-01
04260531790016V-DENUPETV-DENUPET 135V-DEN-1352022-03-01
04260531790023V-DENUPETV-DENUPET 140V-DEN-1402022-03-01
04260531790030V-DENUPETV-DENUPET 150V-DEN-1502022-03-01
04260531790054V-DENUPETV-DENUPET 175V-DEN-1752022-03-01
04260531790061V-DENUPETV-DENUPET 200V-DEN-2002022-03-01
04260531790078V-DENUPETV-DENUPET 275V-DEN-2752022-03-01
04260531790085V-DENUPETV-DENUPET 300V-DEN-3002022-03-01
04260531790092V-DENUPETV-DENUPET 600V-DEN-6002022-03-01
04260650070341V-VITWARMV-TS-KIT2024-11-16
04260650070297V-VITWARMV-TS-KIT2024-11-16
04260650070327V-VITFREEZEV-FS-KIT2024-10-16
04260650070273V-VITFREEZEV-FS-KIT2024-10-16
04260650071034V-PVPV-PVP-72024-05-04

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