FDA.reportPublic FDA data

Carbon Fiber Table Top

Primary DI
04046768146044
Brand
Carbon Fiber Table Top
Company
MAQUET GmbH
Model
116016A1
Published
2025-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046768146044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046768146044040467681460444046768146044

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table topA component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315435859
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
04053275000011GETINGE6710GSS67N Model 67102019-02-06
04053275000028GETINGE 6713GSS67N Model 67132019-02-06
04053275000035GETINGE6717GSS67N Model 67172019-02-06
04046768146600Traction Adapter100372AC2025-11-30
04046768151468Connection Bracket100405A02025-11-30
04046768151475Connection Bracket100405F02025-11-30
04046768151567Traction bar with ball for 1160 and 7700100740B02025-11-30
04046768151574Traction bar for 1160 and 7700100741B02025-11-30
04046768112704Disposable cover100729A02025-06-17
04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768151208Retrofit kit head fixation II116036B02024-11-21
04046768000094Connection bracket100208002022-09-22
04046768000124Connector100258002022-09-22
04046768000421Cross-bar attachment100523002022-09-22
04046768000452Support arm100558002022-09-22
04046768001510Head rest adapter100207A02022-09-22
04046768001657Fixture100265A02022-09-22
04046768001688Horseshoe head rest100272A02022-09-22
04046768001695Flat head rest100273A02022-09-22
04046768001701Motorised head rest adjustment100274A02022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00887761943209PadsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGKXJ2025-01-17
00857534006691ORT400 TableIMRIS Imaging, Inc.KXJ2024-10-04
00857534006738ORT200IMRIS Imaging, Inc.KXJ2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGKXJ2024-02-22
00810050245487NADOMICO MED-DEVICE, LLCKXJ2023-05-01
00810050245463NADOMICO MED-DEVICE, LLCKXJ2023-01-13
00887761968424TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761969414PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967632X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967649X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967656X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967724Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967786Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967885PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967915PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967939PadsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03