FDA.reportPublic FDA data

Carl

Primary DI
07350136560200
Brand
Carl
Company
Rini Ergoteknik AB
Model
Rn
Catalog number
120-00133/-00102 -nn
Device description
Surgeon chairs electrical, the “Carl” series are ergonomically designed and are available with various special armrests. The chairs have extensive possibilities for adjusting the backrest and seat and are also easy to raise and lower electrically with the feet.
Published
2023-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07350136560200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350136560200073501365602007350136560200

GMDN Terms#

Term, Definition table
TermDefinition
Operating room stoolA seat, usually padded and height-adjustable, intended to be occupied by operating room (OR) staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in operating theatres or clean-rooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354971327
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350136560217Pedal platformPedal Platform140-00327-nn2026-03-24
07350136560101Carl MechanicalSpring/Swing120-0010n-0n2023-08-18
07350136560002RiEye Mk2SRn100-00105-0n2023-07-13

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
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
05050474617193CATALYS PATIENT CHAIRJOHNSON & JOHNSON SURGICAL VISION, INC.HMD2020-08-01
04560323649004MARCOTAKAGI SEIKO CO.,LTD.HMD2017-04-25
06909071671048MARCOTAKAGI SEIKO CO.,LTD.HMD2016-09-09