FDA.reportPublic FDA data

NA

Primary DI
00724995165307
Brand
NA
Company
STERIS CORPORATION
Model
X-Ray Table Top
Catalog number
BF651
Device description
The Bariatric Table Extenders with 4-inch Pads: Leg Section are radiolucent modular Extenders that increases the width of the Cmax, 4085, 5085 and or 5085SRT Surgical Tables by 28-inches. The set includes two Extenders each for the Leg Section.
Published
2021-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995165307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995165307007249951653077249951653070724995165307

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.

Contacts#

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

Regulatory Flags#

DUNS number
036985604
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403053924V. MuellerLA8506-45LA8506452016-09-24
10724995023833VERIFYDual SpeciesS3062016-09-09
10724995032798DARTNB113NB1132016-09-09
10724995154735VERIFY SIXCESSPCC072PCC0722019-04-19
10724995154742VERIFY SIXCESSPCC073PCC0732019-04-19
00724995000783Revital-Ox Resert4455N94455N92016-09-07
00724995095017Revital-Ox Resert4455AW4455AW2016-09-07
00724995153779AmscoWarming CabinetDJ060144123132020-06-11
00724995153816AmscoWarming CabinetDJ060144331112020-06-11
00724995161392HarmonyAIRM-Series SuspensionLM99APIT2020-06-17
00724995170493HarmonyAIRG-Series SuspensionLK00162020-05-19
00724995185886HarmonyAIRA-Series Suspension SystemLAS30NC012020-05-28
00724995185893HarmonyAIRA-Series Suspension SystemLAS30NC022020-05-28
00724995185909HarmonyAIRA-Series Suspension SystemLAS30NCND2020-05-28
00724995185916HarmonyAIRA-Series Suspension SystemLAS30NC01T2020-05-28
00724995185923HarmonyAIRA-Series Suspension SystemLAS30NC02T2020-05-28
00724995185930HarmonyAIRA-Series Suspension SystemLAS30NCNDT2020-05-28
00724995185947HarmonyAIRA-Series Suspension SystemLAS52NC012020-05-28
00724995185954HarmonyAIRA-Series Suspension SystemLAS52NC022020-05-28
00724995185961HarmonyAIRA-Series Suspension SystemLAS52NCND2020-05-28

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
00724995362348HarmonyAIRSTERIS 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