FDA.reportPublic FDA data

Carl Mechanical

Primary DI
07350136560101
Brand
Carl Mechanical
Company
Rini Ergoteknik AB
Model
Spring/Swing
Catalog number
120-0010n-0n
Device description
Surgeon chair with mechanical height adjustment by an ergonomically designed foot control under the chair. High level of comfort for the surgeon within Eye-, ENT-, Neuro, Plastic-, Dental-, Robot-, and similar types of microsurgery. Can be outfitted with different armrests to match different needs, all easy to use with intuitive settings.
Published
2023-08-18
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
07350136560101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350136560101073501365601017350136560101

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
07350136560200CarlRn120-00133/-00102 -nn2023-08-08
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
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
05050474617193CATALYS PATIENT CHAIRJOHNSON & JOHNSON SURGICAL VISION, INC.HMD2020-08-01
04560323649004MARCOTAKAGI SEIKO CO.,LTD.HMD2017-04-25
06909071671048MARCOTAKAGI SEIKO CO.,LTD.HMD2016-09-09