FDA.report

Globe Scientific

Primary DI
00840095604659
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
2850
Device description
Inoculation Loop, Rigid, 10uL & 1uL, with Calibration Certificate, STERILE, White, Individually Wrapped
Published
2019-11-26
Public version status
Update
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
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095604666PackageGS112In Commercial Distribution
00840095604659PrimaryGS10
00840095610841Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095604666008400956046668400956046660840095604666
00840095604659008400956046598400956046590840095604659
00840095610841008400956108418400956108410840095610841

GMDN Terms

TermDefinition
Inoculating loop 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 processingand/or testing. It typically consists of a slender handle with an attached wire or plastic loop on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840095689656Globe Scientific 154105FS2025-07-07

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