FDA.report

Typenex Medical Inoculation Loop

Primary DI
10810050854976
Brand
Typenex Medical Inoculation Loop
Company
TYPENEX MEDICAL LLC
Model
LP0101
Device description
Inoculation Loop – 1uL
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810050854986PackageGS150In Commercial Distribution
10810050854976PackageGS110In Commercial Distribution
10810050854983PackageGS16In Commercial Distribution
00810050854979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050854986008100508549868100508549860810050854986
1081005085497610810050854976
1081005085498310810050854983
00810050854979008100508549798100508549790810050854979

GMDN Terms

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

TypeValueUnit
Total Volume1Microliter

Sterilization Methods

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

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