FDA.report

NA

Primary DI
05050474520738
Brand
NA
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
OM290901
Catalog number
OM290901
Device description
INSTRUMENT TRAY
Published
2018-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
05050474520738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474520738050504745207385050474520738

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags

DUNS number
103021940
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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