FDA.reportPublic FDA data

Imaging Extension, Long, OPERON D 750-D

Primary DI
10841962110492
Brand
Imaging Extension, Long, OPERON D 750-D
Company
Qfix
Model
8000099
Catalog number
8000099
Device description
Imaging Extension, Long, OPERON D 750-D
Published
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
10841962110492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196211049210841962110492

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length44Inch
Width21Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags#

DUNS number
808875397
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
00841439115305MultiFix 2RT-5411RT-54112026-06-04
00841439115312MultiFix 2 - JointGlowRT-5412RT-54122026-06-04
00841439115329Extremity RiserRT-5413RT-54132026-06-04
00841439115336Extremity Riser - JointGlowRT-5414RT-54142026-06-04
00841439115343MultiFix Indexing PostRT-5415RT-54152026-06-04
00841962120500Single Hand Extremity FibreplastRT-E778KPR2HRT-E778KPR2H2026-06-05
00841962120517Knee / Elbow Extremity FibreplastRT-E778KPR2NERT-E778KPR2NE2026-06-05
00841962120524Foot Extremity FibreplastRT-E778KPR3FTRT-E778KPR3FT2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastRT-E778KPR3HSRT-E778KPR3HS2026-06-05
00841439115237Opti-TattUTRT-4100UTRT-41002026-05-29
00841439115244Opti-TattUTRT-4200UTRT-42002026-05-29
00841439115251Opti-TattUTRT-4300UTRT-43002026-05-29
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120425Opti Handle Thermoplastic AdapterRT-4546-05RT-4546-052026-05-18
00841962120319Aquaplast PS™PS-1309CSSPS-1309CSS2025-07-09
10841962107447Aquaplast PS™PS-1307PS-13072016-09-13
10841962108307VacQfix™RT-4517-4079VF15RT-4517-4079VF152016-09-13
10841962109090QUANTUM™ CT OverlayRT-4550TE24RT-4550TE242016-09-13
10841962109274kVue™ EdgeRT-4551KVERT-4551KVE2016-09-13
10841962109403Stradivarius™RT-4558CB01RT-4558CB012016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953255315NAGE Medical Systems, L.L.C.KXJ2026-07-08
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