FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044205312
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
258-4048-G90
Catalog number
258-4048-G90
Device description
PROCESS EMBEDDING CASSETTE
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KETFILTERS, CELL COLLECTION, TISSUE PROCESSING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KETFilters, Cell Collection, Tissue ProcessingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044205213PrimaryGS10
00810044205312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044205213008100442052138100442052130810044205213
00810044205312008100442053128100442053120810044205312

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue cassette IVD, laboratory processingA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a synthetic polymer container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(716)876-9855christine.koch@caplugs.com

Regulatory Flags#

DUNS number
098203461
Device count
500
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
false
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
00810044208375Caplugs/Evergreen127-1758-B20127-1758-B202026-02-06
00810044208382Caplugs/Evergreen127-1758-Y20127-1758-Y202026-02-06
00810044206944Caplugs/Evergreen208-3366-050208-3366-0502024-05-31
00810044206951Caplugs/Evergreen208-3367-050208-3367-0502024-05-31
00810044206968Caplugs/Evergreen208-3368-050208-3368-0502024-05-31
00810044206975Caplugs/Evergreen208-3383-03K208-3383-03K2024-05-31
00810044206982Caplugs/Evergreen208-3383-060208-3383-0602024-05-31
00810044206999Caplugs/Evergreen208-3384-060208-3384-0602024-05-31
00810044207002Caplugs/Evergreen208-3385-060208-3385-0602024-05-31
00810044207019Caplugs/Evergreen208-3385-06R208-3385-06R2024-05-31
00810044207026Caplugs/Evergreen208-3385-06S208-3385-06S2024-05-31
00810044207033Caplugs/Evergreen208-3376-050208-3376-0502024-05-31
00810044207040Caplugs/Evergreen208-3377-050208-3377-0502024-05-31
00810044207057Caplugs/Evergreen208-3378-050208-3378-0502024-05-31
00810044207064Caplugs/Evergreen208-3392-060208-3392-0602024-05-31
00810044207071Caplugs/Evergreen208-3393-060208-3393-0602024-05-31
00810044207088Caplugs/Evergreen208-3394-060208-3394-0602024-05-31
00810044207095Caplugs/Evergreen208-1289-03S208-1289-03S2024-05-31
00810044207101Caplugs/Evergreen208-3049-030208-3049-0302024-05-31
00810044207118Caplugs/Evergreen208-3049-03S208-3049-03S2024-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410078PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410085PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410313PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410504PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410511PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
04260649292068cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292082cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292105cytoQ®SABEU GmbH & Co. KGKET2026-02-10
07898027900792CELLPRESERV KOLPLASTKolplast C IKET2023-11-29
10630094188505Bioseal Inc.BIOSEALKET2023-10-05
10630094188512Bioseal Inc.BIOSEALKET2023-10-05
10630094188604Bioseal Inc.BIOSEALKET2023-10-05
10630094887026Bioseal Inc.BIOSEALKET2023-10-05
10630094889051Bioseal Inc.BIOSEALKET2023-10-05
20853778007009Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
10853778007132BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
10853778007149Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
10853778007156BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21
30853778007136BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
40853778007003BMP Medical Double Cytology Funnel w/ White Card (Bulk)Biomedical Polymers, Inc.KET2023-08-21
06974669350339MDHCMDHC Life Technologies (Kunshan) Co., LTD.KET2023-07-06
00817517026825Marketlab, IncMARKETLAB INC.KET2023-03-17
00817517025101Marketlab, IncMARKETLAB INC.KET2023-02-15
00810072351197Graft Slivering BoardCole Instruments IncKET2022-12-08
00810044205251Caplugs/EvergreenCAPlugsKET2021-12-31
00810044205268Caplugs/EvergreenCAPlugsKET2021-12-31
00810044205275Caplugs/EvergreenCAPlugsKET2021-12-31
00810044205282Caplugs/EvergreenCAPlugsKET2021-12-31
00810044205299Caplugs/EvergreenCAPlugsKET2021-12-31
00810044205305Caplugs/EvergreenCAPlugsKET2021-12-31