FDA.reportPublic FDA data

IT 1060.i

Primary DI
04260647940015
Brand
IT 1060.i
Company
AKRUS GmbH & Co. KG
Model
470.000000
Device description
The instrument tables are height-adjustable equipment tables. They are used to hold and supply power to ophthalmic devices and accessories for the treatment of seated patients. The IT 1060.i instrument table is suitable for wheelchair users. For treatment, push the wheelchair with the front castors onto the base plate of the instrument table. The castors are secured against rolling away by the grooves in the base plate.
Published
2023-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray
HRJTable, Instrument, Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1
HRJTable, Instrument, Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260647940015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260647940015042606479400154260647940015

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic instrument table, line-poweredA mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494121791930sales@akrus.de

Regulatory Flags#

DUNS number
324099522
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
04260647940022Sliding keyboard shelf470.0320002025-11-28
04260647940039Footrest extension472.0100032025-11-28
04260647941494SC 5010 ES242.000000, 242.0000012025-11-28
04260647941500SC 5010 HS275.000000, 275.0000032025-11-28
04260647941524ak 5010 MBS277.000000, 277.0000052025-11-28
04260647941579SB 5010 ES649.0000002025-11-28
04260647941586SB 5010 HS650.0000002025-11-28
04260647942040Additive Back support MBS277.0320102025-11-28
04260647942057Additive Back support (viscoel.) MBS277.0320202025-11-28
04260647942064Adapter footrest MBS277.9503002025-11-28
04260647945492Doctor stool ak 445280.0010002025-11-28
04260647945508Doctor stool ak 445280.0010012025-11-28
04260647945522Doctor stool ak 445280.0010032025-11-28
04260647945546Doctor stool ak 445280.0020002025-11-28
04260647945553Doctor stool ak 445280.0020012025-11-28
04260647945577Doctor stool ak 445280.0020032025-11-28
04260647945584Doctor stool ak 445280.0020072025-11-28
04260647945591Doctor stool ak 445280.0020082025-11-28
04260647945607Doctor stool ak 445280.0020092025-11-28
04260647945652Doctor stool ak 445280.0020102025-11-28

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00628308210435S4OptikINNOVA Medical Ophthalmics IncHRJ2026-03-31
00628308210459S4OptikINNOVA Medical Ophthalmics IncHRJ2026-03-31
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
07640152573989FISSOBaitella AGFWZ2025-10-13
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08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28
00615521032203ALLENHILL-ROM, INC.FWZ2023-06-02
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