FDA.report

V. Mueller

Primary DI
10885403185311
Brand
V. Mueller
Company
STERIS CORPORATION
Model
TB1-10
Catalog number
TB1-10
Device description
GENESIS BASKET ID TAG STANDARD, MIDNIGHT BLUE 1/2 X 1-3/4" (1.3 X 4.4CM)
Published
2018-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403185311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540318531110885403185311

GMDN Terms

TermDefinition
Device operating status label/tag, reusableA label or a tag intended to indicate the operating/calibration status (e.g., calibrated, repair required, out of service) and/or sterility record of the device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed to a specific standard. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags

DUNS number
021599373
Device count
1
DM exempt
false
Premarket exempt
false
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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00724995222031NATable ExtensionBF002612026-02-13
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00724995222079NATable ExtensionBF002652026-02-13

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