FDA.report

Globe Scientific

Primary DI
00840095601702
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
113141Y
Device description
Cap, Snap, 16mm, PE, for Vacuum and Test Tubes, Yellow
Published
2019-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00840095601719PackageGS16In Commercial Distribution
00840095601702PrimaryGS10
00840095609364Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095601719008400956017198400956017190840095601719
00840095601702008400956017028400956017020840095601702
00840095609364008400956093648400956093640840095609364

GMDN Terms

TermDefinition
Test tube/reservoir capA covering intended to be used to seal the top of a test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
Device count
1000
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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