FDA UDI In Commercial Distribution 🇺🇸 United States

Brasseler USA

DI: 00887919628958 · Model: 5017989U0 · Peter Brasseler Holdings, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Brasseler USA
Primary DI
00887919628958
Version / Model
5017989U0
Company Name
Peter Brasseler Holdings, LLC
Labeler DUNS
082080136
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-01
Public Version
1
Public Version Date
2022-12-09
Public Version Status
New
Public Device Record Key
5b68a1b1-65e3-4d17-8ddb-c6d83d33187d

Device Description

SEQ GP/PP 04 15-60 ASST 300P

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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

GMDN Terms

Code Name
45081 Synthetic gutta-percha

Identifiers

Type ID
Primary 00887919628958