FDA.report

WHITESTAR SIGNATURE SYSTEM, FUSION PUMP

Primary DI
05050474534445
Brand
WHITESTAR SIGNATURE SYSTEM, FUSION PUMP
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
OPO71
Catalog number
OPO71
Device description
NEXT GENERATION PHACO DP-PACK
Published
2016-09-02
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
true

Related Records

Contact Domains

Product Codes

CodeName
HQCUnit, phacofragmentation

Product Code Classifications

CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15050474534442PackageGS16In Commercial Distribution
05050474534445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1505047453444215050474534442
05050474534445050504745344455050474534445

GMDN Terms

TermDefinition
Ultrasonic surgical system tubing setA sterile collection of dual-lumen tubing and connectors that are used in an ultrasonic surgical system to transport irrigation fluid through one lumen to the surgical site, and remove the aspirate through the other for collection in a suction bottle/canister. The tubing connects to the system's generator at one end and will typically be fitted with safety connectors; it is used only with systems that include irrigation/aspiration. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
103021940
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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