FDA.reportPublic FDA data

SB 5010 HS

Primary DI
04260647941586
Brand
SB 5010 HS
Company
AKRUS GmbH & Co. KG
Model
650.000000
Device description
The mobile, electrically operated SB 5010 HS / ES surgical bed is designed for the placement and positioning of patients in the required posture during diagnostic and therapeutic proce-dures, as well as during surgical interventions on humans.
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
GDCTable, Operating-Room, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260647941586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260647941586042606479415864260647941586

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
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
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
04260647945669Doctor stool ak 445280.0010062025-11-28

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00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
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00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967816Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967823Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967830Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967878PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967908PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967922PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761968660Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
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00887761967533TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27