FDA.reportPublic FDA data

Typenex Medical Inoculation Loop

Primary DI
10810050854990
Brand
Typenex Medical Inoculation Loop
Company
TYPENEX MEDICAL LLC
Model
LP0201
Device description
Inoculation Loop – 10uL
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050855006PackageGS150In Commercial Distribution
10810050854990PackageGS110In Commercial Distribution
10810050855003PackageGS16In Commercial Distribution
00810050854993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050855006008100508550068100508550060810050855006
1081005085499010810050854990
1081005085500310810050855003
00810050854993008100508549938100508549930810050854993

GMDN Terms#

Term, Definition table
TermDefinition
Inoculating tool IVD, manualA hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Microliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050855815ThermoFlo®60612026-01-26
10810050855805Typenex Introducer SetMS2335S2025-11-17
10810050855782Fibernex Laser SystemLS02012025-07-28
20810050855772Microscope SlidesLC0104B2025-07-14
20810050855765Microscope SlidesPS0204W2025-07-08
20810050855741Microscope SlidesPS0404WXT2025-06-17
20810050855758Microscope SlidesPS0404YXT2025-06-17
00810050855457Rad ControlRT03022025-05-23
00810050855471Rad ControlRT03012025-05-23
20810050855697Microscope SldiesLC01012025-02-03
20810050855703Microscope SlidesLC02032025-02-03
20810050855710Microscope SlidesLC01042025-02-03
20810050855727Microscope Slides LC01032025-02-03
20810050855734Microscope SlidesPS0202WXL2025-02-03
20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
10810050855669ThermoFlo®60012024-11-20
20810050855673Microscope SlidesPS0201WXL2024-11-18

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Primary DI, Brand, Company table
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04250317537577PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317554611PrecolumnChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317555281PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317558022PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
09120123910015Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
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06979203760049Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760056Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760018Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-08
04049016152101Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04049016152125Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04250317510174TubeChromsystems Instruments + Chemicals GmbHLXG2025-07-31
04260170881090Q-graft control deviceHuman Med AGLXG2025-07-30
04260170881106Q-graft collectorHuman Med AGLXG2025-07-30
14260170881608Q-graft disposable setHuman Med AGLXG2025-07-30
14260170881615Q-graft centrifugation setHuman Med AGLXG2025-07-30
17290020288001CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288018CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288025CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288032CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288049CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288056CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288063CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288070CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20