FDA.report

Universal Pipette Tip

Primary DI
00810050853590
Brand
Universal Pipette Tip
Company
TYPENEX MEDICAL LLC
Model
PT0101S
Device description
Universal Pipette Tips - Filter - 200 microliter - Sterile
Published
2021-04-22
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
JRCMicro Pipette

Product Code Classifications

CodeDeviceSpecialtyClass
JRCMicro PipetteClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810050853597PackageGS196In Commercial Distribution
20810050853594PackageGS110In Commercial Distribution
40810050853598PackageGS15In Commercial Distribution
00810050853590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085359710810050853597
2081005085359420810050853594
4081005085359840810050853598
00810050853590008100508535908100508535900810050853590

GMDN Terms

TermDefinition
Mechanical micropipetteA manually-operated device typically used in the laboratory to withdraw, transfer, and inject minute volumes of fluid materials (e.g., microlitres or smaller). The device is typically hand-held and operates through an internal mechanism powered by finger depressions of the user; it can have a single channel or a multichannel piston/cylinder assembly. The device transfers consistent volumes of substance into one or several receptacles simultaneously. The device may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range.

Device Sizes

TypeValueUnit
Total Volume200Microliter

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
false
Sterilization required before use
false

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00810050855457Rad ControlRT03022025-05-23
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