FDA.report

Autoclavable Plastic Sterilisation Tray with mat, small

Primary DI
10697660003679
Brand
Autoclavable Plastic Sterilisation Tray with mat, small
Company
Oculo-Plastik Inc
Model
27-6530
Device description
Autoclavable Plastic Sterilisation Tray with mat, small
Published
2019-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSMTray, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10697660003679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1069766000367910697660003679

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Device Sizes

TypeValueUnit
Length6.5Inch
Length165Millimeter
Width3Inch
Width80Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
514-381-3292sales@oculoplastik.com

Regulatory Flags

DUNS number
257382580
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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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