FDA.reportPublic FDA data

NA

Primary DI
00724995203276
Brand
NA
Company
STERIS CORPORATION
Model
ShroudGuard
Catalog number
BF067
Device description
The ShroudGuard Surround for 3000 Series Surgical Tables protects the OR table base on four sides with a sturdy, metal structure that prevents accidental damage caused by the pedestal shroud cladding being lowered onto objects placed near or against the pedestal.
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDCTABLE, OPERATING-ROOM, ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995203276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995203276007249952032767249952032760724995203276

GMDN Terms#

Term, Definition table
TermDefinition
Operating table pedestal protectorA device in the form of a fence/surround intended to protect the pedestal/cladding of an operating table from direct physical damage. It is a multi-piece shield/guard which clips together around the perimeter of the base of the pedestal. This is a reusable device.

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
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
00728564070009Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00728564075004Assist Powered Medical Exam TableThe Brewer Company LLCGDC2025-11-10
00810050245562NADOMICO MED-DEVICE, LLCGDC2025-09-24
00724995244880NASTERIS CORPORATIONGDC2025-05-05
00724995244965NASTERIS CORPORATIONGDC2025-05-05
00724995245030CMAX XRAY Remote ControlSTERIS CORPORATIONGDC2025-05-05
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGGDC2025-01-17
00857534006721Headboard AssemblyIMRIS Imaging, Inc.GDC2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGGDC2023-01-17
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967816Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967823Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967830Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967878PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967908PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967922PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761968660Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967526TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27
00887761967533TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27