FDA.report

ENDORET® TEST-TUBE RACK FOR 9 ML TUBES

Primary DI
08435389805014
Brand
ENDORET® TEST-TUBE RACK FOR 9 ML TUBES
Company
BIOTECHNOLOGY INSTITUTE SL
Model
GT16
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08435389805014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389805014084353898050148435389805014

GMDN Terms

TermDefinition
Test tube rackA non-sterile device designed to hold test tubes in an upright and secured position. It is typically made of metal and/or plastic and consists of a base plate upon which it stands and second plate containing a mesh (grid of square slots) or round holes which is supported at a given height with spacers or diving walls. It is typically used in a clinical laboratory. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
461665312
Device count
1
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
true
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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