FDA UDI In Commercial Distribution 🇺🇸 United States

STANDARD BURS

DI: 00887919340850 · Model: 10-C0617 · Peter Brasseler Holdings, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
STANDARD BURS
Primary DI
00887919340850
Version / Model
10-C0617
Company Name
Peter Brasseler Holdings, LLC
Labeler DUNS
082080136
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-03-13
Public Version
1
Public Version Date
2025-03-21
Public Version Status
New
Public Device Record Key
d409a19b-71f4-49b6-8434-02043f2d292c

Device Description

10-C0617

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Radiation Sterilization

Product Codes

Code Name
GFF BUR, SURGICAL, GENERAL & PLASTIC SURGERY

GMDN Terms

Code Name
45553 Orthopaedic bur, single-use

Identifiers

Type ID
Primary 00887919340850