FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDCTABLE, OPERATING-ROOM, ELECTRICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995203276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995203276007249952032767249952032760724995203276

GMDN Terms

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

Contacts

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
true
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

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Primary DIBrandCompanyProduct codePublished
00615521070069ALLENHILL-ROM, INC.GDC2026-02-27
00724995244972NASTERIS CORPORATIONGDC2026-02-13
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04260647941579SB 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
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