FDA.reportPublic FDA data

NA

Primary DI
00724995164362
Brand
NA
Company
STERIS CORPORATION
Model
BF093
Catalog number
BF093
Device description
The 5085SRT Standard Accessory Package with Foot Extension is used with the 5085 SRT 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
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090136000STERIS CMAX XLT SURGICAL TABLESTERIS Corporation2009-03-20FQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995164362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995164362007249951643627249951643620724995164362

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

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
10885403107030V. MuellerR1134R11342016-09-23
10885403133824V. MuellerTB1-1TB112018-03-19
10885403133831V. MuellerTB1-2TB122018-03-19
10885403133848V. MuellerTB1-5TB152018-03-19
10885403133855V. MuellerTB1-6TB162018-03-19
10885403133862V. MuellerTC2-2TC222016-09-24
10885403179020V. MuellerR1142R11422016-09-23
10885403179037V. MuellerR1623R16232018-03-19
10885403179129V. MuellerR1589R15892016-09-23
10885403179136V. MuellerR1590R15902016-09-23
10885403185311V. MuellerTB1-10TB1102018-03-19
10885403185328V. MuellerTB1-12TB1122018-03-19
10885403185335V. MuellerTB1-3TB132018-03-19
10885403185342V. MuellerTB1-4TB142018-03-19
10885403185359V. MuellerTB1-7TB172018-03-19
10885403185366V. MuellerTB2-1TB212018-03-19
10885403185373V. MuellerTB2-10TB2102018-03-19
10885403185380V. MuellerTB2-12TB2122018-03-19
10885403185397V. MuellerTB2-2TB222018-03-19
10885403185403V. MuellerTB2-3TB232018-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
00724995362317HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362324HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362331HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678757ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678788ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678887ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376729473ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00724995246136HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246143HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246150HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246167HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246174HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246181HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246198HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246204HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246211HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246228HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246235HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246242HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246259HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246266HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246273HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246280HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246297HarmonyAIRSTERIS CORPORATIONFQO2025-11-19