FDA.report

Sterilization Container

Primary DI
00840199514441
Brand
Sterilization Container
Company
KOROS U.S.A., INC.
Model
7328-96
Catalog number
7328-96
Device description
Sterilization Container 21.5x10.5x3
Published
2021-10-01
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
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications

CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840199514441Direct MarkingGS10
10840199514448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199514441008401995144418401995144410840199514441
1084019951444810840199514448

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
true

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