FDA UDI In Commercial Distribution 🇺🇸 United States

TriLeap Lower Extremity Anatomic Plating System

DI: 00810112592573 · Model: 2.7 mm Drill Bit for Standard Technique · CROSSROADS EXTREMITY SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TriLeap Lower Extremity Anatomic Plating System
Primary DI
00810112592573
Version / Model
2.7 mm Drill Bit for Standard Technique
Catalog Number
03.900.334
Company Name
CROSSROADS EXTREMITY SYSTEMS
Labeler DUNS
058864308
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-23
Public Version
1
Public Version Date
2024-03-04
Public Version Status
New
Public Device Record Key
7e02be63-0432-4d3c-923f-4459c87d7ae6

Device Description

2.7 mm Drill Bit for Standard Technique

Device Characteristics

Single Use
No
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HTW Bit, Drill

GMDN Terms

Code Name
32390 Fluted surgical drill bit, reusable

Identifiers

Type ID
Primary 00810112592573