FDA.reportPublic FDA data

ELITE

Primary DI
00724995219826
Brand
ELITE
Company
STERIS CORPORATION
Model
BF465
Catalog number
BF465
Device description
Medium ELITE Prone Headrest is ideal for positioning and stabilizing the patient's head for all supine procedures with the added benefit of pressure management.
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWGSURGICAL TABLE CUSHION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995219826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995219826007249952198267249952198260724995219826

GMDN Terms#

Term, Definition table
TermDefinition
Operating/examination/treatment table headrest, reusableA device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest typically made of metal and synthetic materials that incorporate a cushion or pad that provides a softer surface for the patient's head to rest upon. It is available in various shapes and sizes and will typically include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius50 Degrees Celsius

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
Lot or batch
true
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
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10810087353343CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087354005CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350908CoulmedCoulmed Products Group LLCLWG2023-01-06
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10810087350922CoulmedCoulmed Products Group LLCLWG2023-01-06
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