FDA.reportPublic FDA data

NA

Primary DI
00724995244996
Brand
NA
Company
STERIS CORPORATION
Model
TAB830H
Catalog number
BF790
Device description
CMAX Xray Headrest Adaptors (HEAD02 Interface) is used with the CMAX Xray Surgical Table.
Published
2025-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBMHEADREST, NEUROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBMHeadrest, NeurosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995177782PreviousGS10
00724995244996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995177782007249951777827249951777820724995177782
00724995244996007249952449967249952449960724995244996

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
Premarket exempt
true
Serial number
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
Primary DIBrandCompanyProduct codePublished
00724995244910NASTERIS CORPORATIONHBM2025-05-05
04250435529867DORO LUCENT® iMRI Transfer Collision Indicator Black Forest Medical GmbHHBM2025-02-10
00850068304172SBHSBH SurgicalHBM2024-12-06
00850068304158SBHSBH SurgicalHBM2024-12-03
00850068304165SBHSBH SurgicalHBM2024-12-03
00850068304189SBHSBH SurgicalHBM2024-12-03
00850068304196SBHSBH SurgicalHBM2024-12-03
00724995229290NASTERIS CORPORATIONHBM2024-11-25
00857534006837Horseshoe HeadrestIMRIS Imaging, Inc.HBM2024-11-01
00857534006844Horseshoe HeadrestIMRIS Imaging, Inc.HBM2024-11-01
04251554151502Reinforcement-Armmedical bees GmbHHBM2024-10-14
04250435501320DORO® Extensionbar Horseshoe Black Forest Medical GmbHHBM2024-07-11
00724995229160NASTERIS CORPORATIONHBM2024-03-08
00724995229177NASTERIS CORPORATIONHBM2024-03-08
00724995229184NASTERIS CORPORATIONHBM2024-03-08
00724995229191NASTERIS CORPORATIONHBM2024-03-08
00724995229207NASTERIS CORPORATIONHBM2024-03-08
00724995229214NASTERIS CORPORATIONHBM2024-03-08
00724995177782NASTERISHBM2023-12-11
04250435539378DORO® LUCENT iMRI Coil Connector IMRISBlack Forest Medical GmbHHBM2023-10-25
04250435539521DORO® LUCENT iMRI Interface Adaptor IMRISBlack Forest Medical GmbHHBM2023-10-25
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00883475954647Tightening DriverCHARMANT INC.HBM2023-09-18
00883475954654U-Bar DistalCHARMANT INC.HBM2023-09-18
00883475954661U-Bar ProximalCHARMANT INC.HBM2023-09-18
00883475954678Vertical Post TiltedCHARMANT INC.HBM2023-09-18
00883475954685Vertical Post UprightCHARMANT INC.HBM2023-09-18
00883475954692Fukushima Universal Holding SystemCHARMANT INC.HBM2023-09-18