FDA.reportPublic FDA data

ak 5010 MBS

Primary DI
04260647941524
Brand
ak 5010 MBS
Company
AKRUS GmbH & Co. KG
Model
277.000000, 277.000005
Device description
Mammography chairs are intended for positioning and positioning patients for examinations before and during mammography and stereotactic breast biopsy.
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260647941524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260647941524042606479415244260647941524

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, electricA mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

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
04260647945928Surgeon chair ak 480279.000000279.0000XY; X=0,1,..,9; Y=0,1,...,92026-06-22
04260647946109Doctor stool ak 445280.000000280.W0X0YZ, W,X,Y,Z=0,1,...,92026-06-22
04260647946116Doctor stool ak 446281.000000281.00000X; X=0,1,...,92026-06-22
04260647946123Doctor stool ak 447278.000000278.00X00Y; X,Y=0,1,..,92026-06-22
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
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