FDA.report

Nuvo

Primary DI
07899878061144
Brand
Nuvo
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
CD1099002
Catalog number
CD1099002
Device description
COMPLEMENT CASE (MODEL 2)
Published
2023-08-18
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
K230804000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230804000Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.2023-07-07KCT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899878061144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878061144078998780611447899878061144

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags

DUNS number
906713888
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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