FDA.report

Tissue-Tek® Lab Aid® Ultra™ II

Primary DI
08720177655569
Brand
Tissue-Tek® Lab Aid® Ultra™ II
Company
SAKURA FINETEK U.S.A., INC.
Model
3980
Catalog number
3980
Device description
Trolley
Published
2020-06-20
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
false

Related Records

Contact Domains

Product Codes

CodeName
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08720177655569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08720177655569087201776555698720177655569

GMDN Terms

TermDefinition
Endoscope transport trolley trayA support platform designed as a flat, shallow vessel with a raised rim, that functions as a component of an endoscope transport trolley [i.e., it inserts into the trolley (cart)]. It provides a protective space for the transport and short-term storage of a sterile or contaminated endoscope, endoscope accessories, or other sensitive equipment. It is typically made from plastic materials, is available in a variety of sizes, and may be fitted with a cover lid. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags

DUNS number
179135769
Device count
1
DM exempt
true
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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