FDA.reportPublic FDA data

NA

Primary DI
10724995165076
Brand
NA
Company
STERIS CORPORATION
Model
BF452
Catalog number
BF452
Device description
The Shoulder Table Chair Cups are used in conjunction with the Shoulder Table and provide stability for the head and chin during shoulder procedures.
Published
2021-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSSHALTER, HEAD, TRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSSHalter, Head, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995165076PrimaryGS10
00724995165079Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499516507610724995165076
00724995165079007249951650797249951650790724995165079

GMDN Terms#

Term, Definition table
TermDefinition
Medical table restraint anchorA device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
036985604
Device count
10
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
10885403015960V. MuellerBP0-1ABP01A2017-11-17
10885403015977V. MuellerBP0-2ABP02A2017-11-17
10885403015991V. MuellerBP0-2VBP02V2017-11-17
10885403016004V. MuellerBP1-1ASBP11AS2017-11-17
10885403016011V. MuellerBP1-2ABP12A2017-11-17
10885403016035V. MuellerBP1-2ASBP12AS2017-11-17
10885403016066V. MuellerBP1-2VBP12V2017-11-17
10885403016073V. MuellerBP1-2VSBP12VS2017-11-17
10885403016080V. MuellerBP1-3ABP13A2017-11-17
10885403016103V. MuellerBP1-3VBP13V2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756013154DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013161DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013109DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013116DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013123DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013130DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013147DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
50749756013159DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
50749756013166DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013208DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756015608DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756015615DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756878449DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-20
00749756031547DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-06-30
50749756031542DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-06-30
00724995165079NASTERIS CORPORATIONHSS2021-04-23
00889024373518NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.HSS2021-03-03
00889024373587NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.HSS2021-03-03
00822383102986DRIVEMEDICALDrive Devilbiss HealthcareHSS2019-06-21
00822383302980DRIVEMEDICALDrive Devilbiss HealthcareHSS2019-06-21
00822383561738DriveDrive Devilbiss HealthcareHSS2019-06-21
00842430106194Assy, Head Halter and Chin CupMIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2019-01-18
00842430106200DISPOSABLE HEAD HALTERMIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2018-10-17
10842430106207HEAD HALTER, DISPOSABLE MIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2018-10-17