FDA.reportPublic FDA data

NA

Primary DI
00724995164669
Brand
NA
Company
STERIS CORPORATION
Model
BF807
Catalog number
BF807
Device description
The OrthoVision Standard Accessory Package is used with STERIS OrthoVision Surgical Table.
Published
2021-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEBTable, Surgical With Orthopedic Accessories, ManualGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905816000ORTHOVISION TABLEAmerican Sterilizer Co.1991-03-06JEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995164669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995164669007249951646697249951646690724995164669

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic operating table, electrohydraulicA mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to support a patient and to provide traction for the limb(s) of the patient (upper or lower extremity) during orthopaedic surgical procedures. Its surface consists of sections that can be height-adjusted in relation to the section supporting the patient's trunk, and the sections that initially support the legs which are lowered once the patient has been placed in traction. Broken bones can be drawn apart, repositioned, and set to the correct position.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536822543Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822550Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822567Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822574Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822581Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822598Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822604Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822611Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822628Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822635Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822642Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
04251732800383X-Ray Top Seat section PST 500Jörg & Sohn GmbHJEB2026-05-18
04251732800406X-Ray Top Back section PST 500 UJörg & Sohn GmbHJEB2026-05-18
04251732800413Cart for X-Ray TopsJörg & Sohn GmbHJEB2026-05-18
04251732800420Pad leg section light high H GJörg & Sohn GmbHJEB2026-05-18
04251732800437Clamshell Armboard PadJörg & Sohn GmbHJEB2026-05-18
00190776418670MillenniumAvalign Technologies, Inc.JEB2026-04-09
04251732800338X-Ray Top Head sectionJörg & Sohn GmbHJEB2025-06-26
04251732800345X-Ray Top Back section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800352X-Ray Top Seat section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800369X-Ray Top Universal sectionJörg & Sohn GmbHJEB2025-06-26
04251732800376X-Ray Top Leg section one partJörg & Sohn GmbHJEB2025-06-26
G611BIO110210Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110220Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110230Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110240Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024B0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024C0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110310Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110320Alliant BiotechMEDISURGE LLCJEB2024-08-16