FDA.report

INTRALASE TECHNOLOGY PI

Primary DI
05050474655690
Brand
INTRALASE TECHNOLOGY PI
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
0155-1825
Catalog number
0155-1825
Device description
ASSY, 20 PACK,PATIENT INTERFACE, STERILE
Published
2023-08-11
Public version status
New
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
OOEOphthalmic femtosecond laser

Product Code Classifications

CodeDeviceSpecialtyClass
OOEOphthalmic Femtosecond LaserOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474655690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474655690050504746556905050474655690

GMDN Terms

TermDefinition
Laser beam delivery unit holderA device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
010130626
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
true
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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05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

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05050474738553ELITAJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
07640167750573FEMTOSIE AG, Surgical Instrument EngineeringOOE2022-06-10
07640167751334Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751341Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751358Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751365Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751372Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751389Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
05050474709508CATALYS SYSTEMOPTIMEDICA CORPORATIONOOE2020-08-19
07640167751051Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751068Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751082Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751143Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751129Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751105Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751167Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
05050474609761LIQUID OPTICS INTERFACEJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2018-06-08
05050474609778LIQUID OPTICS INTERFACEJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2018-06-08
05050474651487LIQUID OPTICS INTERFACEJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2018-06-08
05050474617186CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2018-04-19
05050474604827LIQUID OPTICS INTERFACEOPTIMEDICA CORPORATIONOOE2017-12-01
04050555002895VICTUS™ Femtosecond Laser PlatformTechnolas Perfect Vision GmbHOOE2016-09-24
10380659908191WaveLightAlcon Laboratories, Inc.OOE2016-09-24
00380659909412WaveLightAlcon Laboratories, Inc.OOE2016-09-24
00380659981623LenSxAlcon Laboratories, Inc.OOE2016-09-24
07640167750016FEMTOLDVSIE AG, Surgical Instrument EngineeringOOE2016-09-15
05050474604803LIQUID OPTICS INTERFACEOPTIMEDICA CORPORATIONOOE2016-09-02