FDA.reportPublic FDA data

Britedent

Primary DI
D974BSI12432
Brand
Britedent
Company
Bright Supply, Inc.
Model
BSI-1243
Device description
(4.25" x 12") Sterilization Pouches
Published
2022-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D974BSI12432PackageHIBCC10In Commercial Distribution
D974BSI12431PrimaryHIBCC0
D974BSI12430Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124117012
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
D974BSI20031BritedentBSI-20032024-06-07
D974BSI55001BritedentBSI-55002025-08-21
D974BSI55002BritedentBSI-55002025-08-21
D974BSI29111BritedentBSI-29112025-03-11
D974BSI29112BritedentBSI-29112025-03-11
D974BSI01021BritedentBSI-01022020-11-26
D974BSI01031BritedentBSI-01032021-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05