FDA.report

Instrument Case

Primary DI
09321502043953
Brand
Instrument Case
Company
Cochlear Bone Anchored Solutions AB
Model
P1340904
Catalog number
P1340904
Published
2023-05-19
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

Contact Domains

Product Codes

CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications

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

Premarket Submissions

SubmissionSupplement
K231604000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231604000Instrument CaseCochlear Americas2023-08-24KCT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09321502043953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09321502043953093215020439539321502043953

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags

DUNS number
559784736
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
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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