FDA.reportPublic FDA data

KOLPLAST

Primary DI
07898027908682
Brand
KOLPLAST
Company
Kolplast C I
Model
SOL SALINA 3ML/2SWAB T10 EST
Catalog number
10.4118
Published
2023-11-29
Public version status
New
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
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898027908682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898027908682078980279086827898027908682

GMDN Terms#

Term, Definition table
TermDefinition
Saline suspension medium/diluent IVDA saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
903963889
Device count
1
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
07898027905902KOLPLASTStandard2019-09-13
07898027900792CELLPRESERV KOLPLASTFILTRO GIN CELLPRESERV10.13472023-11-29
07898027901355KOLPLASTRETOSIGMOIDOSCOPIO10.13822023-11-29
07898027902130VAGISPEC KOLPLASTESPEC VAG VAGISPEC G LUB E9007009232023-11-29
07898027902154VAGISPEC KOLPLASTESPEC VAG KOLPLAST G LONGO10.13292023-11-29
07898027902161VAGISPEC KOLPLASTESPEC VAG KOLPLAST G LONGO EST10.13302023-11-29
07898027903038VAGISPEC KOLPLASTESPECULO VAG KOLPLAST VIRGEM EKPV2023-11-29
07898027903311KOLPLASTRETOSIGMOIDOSCOPIORETO2023-11-29
07898027903656VAGISPEC KOLPLASTESPEC VAG VAGISPEC P NLUB E9001009212023-11-29
07898027903663VAGISPEC KOLPLASTESPEC VAG VAGISPEC P E LUB9001009232023-11-29
07898027903687VAGISPEC KOLPLASTESPEC VAG VAGISPEC G E NLUB9007009212023-11-29
07898027904110VAGISPEC KOLPLASTESPECULO VAG KOLPLAST M E9054009212023-11-29
07898027904127VAGISPEC KOLPLASTESPEC VAG VAGISPEC M E LUB9054009232023-11-29
07898027905353KOLPLASTSWAB HASTE REGULAR D2,5 FP EST10.41092023-11-29
07898027905490CELLPRESERV KOLPLASTCELLPRESERV GLASS SLIDE4001010982023-11-29
07898027905988VAGISPEC KOLPLASTESPECULO VAG KOLPLAST P NE9001002102023-11-29
07898027906015VAGISPEC KOLPLASTESPECULO VAG KOLPLAST M NE9054002102023-11-29
07898027906312VAGISPEC KOLPLASTESPECULO VAG KOLPLAST G NE9007002102023-11-29
07898027907074VAGISPEC KOLPLASTESPEC VAG KOLP M KOLPLUX NE10.10382023-11-29
07898027907159VAGISPEC KOLPLASTESPEC VAG KOLP M KOLPLUX NE 2510.12022023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B645T0466EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0486EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0749EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0759EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B6451B265EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6451R007EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645GB477EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0006EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0246EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6452P195EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P145EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P459EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645GB285EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0448EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0487EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
10382902212611BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
16972698600408KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
18053326001021BHI BROTHCOPAN ITALIA SPAJSG2023-03-03
00848838002878REMELREMEL, INC.JSG2022-12-23
00848838002946REMELREMEL, INC.JSG2022-12-23
00848838002960REMELREMEL, INC.JSG2022-12-23
00848838003363REMELREMEL, INC.JSG2022-12-23
00848838003394REMELREMEL, INC.JSG2022-12-23
00848838003721REMELREMEL, INC.JSG2022-12-23
00848838003912REMELREMEL, INC.JSG2022-12-23
00848838004537REMELREMEL, INC.JSG2022-12-23
00848838004575REMELREMEL, INC.JSG2022-12-23
00848838004612REMELREMEL, INC.JSG2022-12-23