FDA UDI In Commercial Distribution 🇺🇸 United States

BEYOND® BlueSeal® Gingival Protection (5 pack)

DI: 00857848007209 · Model: BY-PD02205 · Beyond International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5

Basic Information

Brand Name
BEYOND® BlueSeal® Gingival Protection (5 pack)
Primary DI
00857848007209
Version / Model
BY-PD02205
Company Name
Beyond International Inc.
Labeler DUNS
080721790
Distribution Status
In Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2022-12-23
Public Version
1
Public Version Date
2023-01-02
Public Version Status
New
Public Device Record Key
1a47f8f6-fc6d-4855-862c-3e9d97cb8025

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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIE Dam, Rubber

GMDN Terms

Code Name
57964 Gingiva bleaching protector

Identifiers

Type ID
Primary 00857848007209
Unit of Use 00857848007766