FDA.reportPublic FDA data

Britedent

Primary DI
D974BSI01031
Brand
Britedent
Company
Bright Supply, Inc.
Model
BSI-0103
Device description
Barrier Film Pink
Published
2021-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D974BSI01032PackageHIBCC8In Commercial Distribution
D974BSI01031PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape dispenserA device intended to be used to dispense sterile packs of instrument/equipment drapes that are normally sterile and used as a protective covering for various surgical and/or non-surgical instruments/equipment [e.g., a surgical or endoscopic tray, an operating room (OR) equipment table, an endoscope and endoscopic instruments]. This device typically holds a stack of drape/liner packs that are placed flat, one on top of the other, so that a user can remove a pack when required. This device is typically wall-mounted and can be made of metal and/or plastic materials.

Regulatory Flags#

DUNS number
124117012
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D974BSI20031BritedentBSI-20032024-06-07
D974BSI55001BritedentBSI-55002025-08-21
D974BSI55002BritedentBSI-55002025-08-21
D974BSI29111BritedentBSI-29112025-03-11
D974BSI29112BritedentBSI-29112025-03-11
D974BSI01021BritedentBSI-01022020-11-26
D974BSI01051BritedentBSI-01052021-08-12
D974BSI25031BritedentBSI-25032023-07-28
D974BSI25041BritedentBSI-25042024-01-18
D974BSI25051BritedentBSI-25052022-03-18
D974BSI25071BritedentBSI-25072021-12-31
D974BSI29011BritedentBSI-29012021-03-30
D974BSI29031BritedentBSI-29032021-04-22
D974BSI29051BritedentBSI-29052021-04-22
D974BSI29061BritedentBSI-29062021-04-22
D974BSI29091BritedentBSI-29092021-03-30
D974BSI29101BritedentBSI-29102021-06-28
D974BSI29121BritedentBSI-29122021-04-22
D974BSI29131BritedentBSI-29132021-06-28
D974BSI29141BritedentBSI-29142021-03-30

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Primary DI, Brand, Company table
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