FDA.reportPublic FDA data

NA

Primary DI
00724995363307
Brand
NA
Company
STERIS CORPORATION
Model
Headrest
Catalog number
BF00509
Device description
Cone Shaped Headrest, 4195/5195, Velcro, 2-inch TLT Pad
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00724995363307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995363307007249953633077249953633070724995363307

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

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
false
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
00724995248444Snowden-Pencer886118V886118V2026-10-27
00724995248451Snowden-Pencer886122V886122V2026-10-27
00724995248468Snowden-Pencer886127V886127V2026-10-27
10885403035562V. MuellerCH8680CH86802020-04-15
10885403035579V. MuellerCH8680-001CH86800012020-04-15
10885403035586V. MuellerCH8681CH86812020-04-15
10885403022470V. MuellerRH600RH6002018-09-14
10885403092084V. MuellerOP0907-601OP09076012018-09-05
10885403092091V. MuellerOP0907-602OP09076022018-09-05
10885403099120V. MuellerOP5000OP50002018-09-07
10885403099137V. MuellerOP5005OP50052018-09-07
10885403099144V. MuellerOP5500OP55002018-09-07
10885403099182V. MuellerOP5505OP55052018-09-07
10885403099199V. MuellerOP5510OP55102018-09-07
10885403099205V. MuellerOP5520OP55202018-09-07
10885403099625V. MuellerOP5666OP56662019-01-02
10885403099717V. MuellerOP5700OP57002019-01-02
10885403099779V. MuellerOP5760OP57602019-01-02
10885403099786V. MuellerOP5761OP57612019-01-02
10885403104909V. MuellerOS4610OS46102018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362980STERISSTERIS CORPORATIONFQO2026-10-08
00724995362997STERISSTERIS CORPORATIONFQO2026-10-08
00724995363000STERISSTERIS CORPORATIONFQO2026-10-08
00724995363024STERISSTERIS CORPORATIONFQO2026-10-08
00724995363031STERISSTERIS CORPORATIONFQO2026-10-08
00724995363048STERISSTERIS CORPORATIONFQO2026-10-08
00724995363116STERISSTERIS CORPORATIONFQO2026-10-08
00724995363123STERISSTERIS CORPORATIONFQO2026-10-08
00724995363147STERISSTERIS CORPORATIONFQO2026-10-08
00724995363154STERISSTERIS CORPORATIONFQO2026-10-08
00724995363161STERISSTERIS CORPORATIONFQO2026-10-08
00724995363291NASTERIS CORPORATIONFQO2026-10-08
00724995363369NASTERIS CORPORATIONFQO2026-10-08
00724995363376NASTERIS CORPORATIONFQO2026-10-08
00724995363383NASTERIS CORPORATIONFQO2026-10-08
00724995363390NASTERIS CORPORATIONFQO2026-10-08
00724995363413NASTERIS CORPORATIONFQO2026-10-08
00724995363901NASTERIS CORPORATIONFQO2026-10-08
00724995363918NASTERIS CORPORATIONFQO2026-10-08
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
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