FDA.reportPublic FDA data

E-Z Jett Cassette Slim 8-place Copper

Primary DI
00840161300416
Brand
E-Z Jett Cassette Slim 8-place Copper
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z911U
Device description
"Holds 8 instruments Compact size, fits the statim Maximizes the space of the Ultrasonic and Autoclave Covers are attached to the cassette and open and fold back easily Syringe Tip comes with to attach to the side of the cassette Dimensions: 7-1/16"" x 4-1/16"" x 1-5/16"" Contains Antimicrobial Protection Autoclavable up to 136°C/277F° Washer-disinfect"
Published
2022-10-04
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

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D68550Z911U0PreviousHIBCC0
00840161300416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161300416008401613004168401613004160840161300416

GMDN Terms#

Term, Definition table
TermDefinition
Instrument transport trolley systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height33Millimeter
Length179Millimeter
Width103Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
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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