FDA UDI In Commercial Distribution 🇺🇸 United States

Fibonacci Lower Extremity Instrument Tray

DI: 00848665027686 · Model: 9937-000 · ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Fibonacci Lower Extremity Instrument Tray
Primary DI
00848665027686
Version / Model
9937-000
Company Name
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Labeler DUNS
117858154
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-01
Public Version
7
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
e0a1389f-d36e-413d-96f5-c544127846be

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
Yes
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
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00848665027686