FDA.reportPublic FDA data

CATALYS PATIENT CHAIR

Primary DI
05050474617193
Brand
CATALYS PATIENT CHAIR
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
0160-6030
Catalog number
0160-6030
Device description
PATIENT CHAIR
Published
2020-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMDChair, ophthalmic, manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMDChair, Ophthalmic, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05050474617193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474617193050504746171935050474617193

GMDN Terms#

Term, Definition table
TermDefinition
Femtosecond ophthalmic solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
010130626
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850020301522Haag-Streit SurgicalHAAG-STREIT USA, INC.HMD2024-01-03
07350136560101Carl MechanicalRini Ergoteknik ABHMD2023-08-18
07350136560200CarlRini Ergoteknik ABHMD2023-08-08
00850020301072RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301133RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301140RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301157RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301232RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301256RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301263RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301270RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301287RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301294RelianceHAAG-STREIT USA, INC.HMD2020-09-09
00850020301300RelianceHAAG-STREIT USA, INC.HMD2020-09-09
04560323649004MARCOTAKAGI SEIKO CO.,LTD.HMD2017-04-25
06909071671048MARCOTAKAGI SEIKO CO.,LTD.HMD2016-09-09