FDA.reportPublic FDA data

Warm Plate

Primary DI
04589700010411
Brand
Warm Plate
Company
REPROLIFE INC.
Model
WP010
Device description
"An Individual package we offer contains 10 plates.The package has product label and letters ""Warm Plate-10 Plate"" are written on it."
Published
2019-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04589700010411PrimaryGS10
45897000122015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589700010411045897000104114589700010411
4589700012201545897000122015

GMDN Terms#

Term, Definition table
TermDefinition
Tissue storage strawA long, thin, tubular sterile device in the form of a straw used for the placement and storage of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It is made of materials to withstand storage in LN2 and is available in a variety of designs that may include a sliding plug or a permeable membrane plug to hold the sample. The sample is inserted into one end of the device and both ends are sealed, typically by using a thermal sealing device, creating an airtight seal to protect the sample from direct contact with the LN2. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691176883
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589700010404Vitri PlateVP0102019-07-12
04589700010015CryotecTEC010BTEC010B2017-08-31
04589700010022CryotecTEC010RTEC010R2017-08-31
04589700010039CryotecTEC010YTEC010Y2017-08-31
04589700010046CryotecTEC010GTEC010G2017-08-31
04589700010053CryotecTEC010WTEC010W2017-08-31
04589700010060CryotecTEC110BTEC110B2017-08-31
04589700010077CryotecTEC110RTEC110R2017-08-31
04589700010084CryotecTEC110YTEC110Y2017-08-31
04589700010091CryotecTEC110GTEC110G2017-08-31
04589700010107CryotecTEC110WTEC110W2017-08-31
04589700010114CryotecTEC004BTEC004B2017-08-31
04589700010121CryotecTEC004RTEC004R2017-08-31
04589700010138CryotecTEC004YTEC004Y2017-08-31
04589700010145CryotecTEC004GTEC004G2017-08-31
04589700010152CryotecTEC004WTEC004W2017-08-31
04589700010169CryotecTEC104BTEC104B2017-08-31
04589700010176CryotecTEC104RTEC104R2017-08-31
04589700010183CryotecTEC104YTEC104Y2017-08-31
04589700010190CryotecTEC104GTEC104G2017-08-31

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