FDA UDI In Commercial Distribution 🇺🇸 United States

Britedent

DI: D974BSI011 · Model: BSI-01 · Bright Supply, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12

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Basic Information

Brand Name
Britedent
Primary DI
D974BSI011
Version / Model
BSI-01
Company Name
Bright Supply, Inc.
Labeler DUNS
124117012
Distribution Status
In Commercial Distribution
Device Count in Pkg
12
Record Status
Published
Publish Date
2021-03-01
Public Version
1
Public Version Date
2021-03-09
Public Version Status
New
Public Device Record Key
308c1caa-fc5c-4d13-8b71-5bde87cab4aa

Device Description

Disposable Impression Trays # 1 Large Upper

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBH Material, Impression Tray, Resin

GMDN Terms

Code Name
16350 Dental impression tray, single-use

Identifiers

Type ID
Package D974BSI012
Primary D974BSI011
Unit of Use D974BSI010