FDA.reportPublic FDA data

NA

Primary DI
00724995158149
Brand
NA
Company
STERIS CORPORATION
Model
BF00025
Catalog number
BF00025
Device description
The Orthopedic IA Board with 2 inch pad has radiolucent technology for increased imaging length, can be used in both normal and reverse orientation and is ideal for endourology applications.
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995158149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995158149007249951581497249951581490724995158149

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
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995023911VERIFYIncubatorS30802021-03-31
00724995023928VERIFYIncubatorS30812021-03-31
00724995023935VERIFYIncubatorS30822021-03-31
00724995095659VERIFYIncubatorS32712021-03-31
00724995301934V. MuellerNL1060NL10602026-10-21
00724995301958V. MuellerNL1064NL10642026-10-21
00724995301972V. MuellerNL1073NL10732026-10-21
00724995301989V. MuellerNL1074NL10742026-10-21
00724995301996V. MuellerNL1075NL10752026-10-21
00724995326906V. MuellerRH1045RH10452026-10-21
00724995239909V. MuellerDP11DP112026-10-15
00724995239916V. MuellerDP12DP122026-10-15
00724995239923V. MuellerDP13DP132026-10-15
00724995239930V. MuellerDP14DP142026-10-15
00724995239947V. MuellerDP15DP152026-10-15
00724995239985V. MuellerED112ED1122026-10-15
00724995239992V. MuellerED15ED152026-10-15
00724995240004V. MuellerED16ED162026-10-15
00724995240011V. MuellerED17ED172026-10-15
00724995240028V. MuellerED19ED192026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21