FDA UDI In Commercial Distribution 🇺🇸 United States

Dynamic Femur Fracture Brace

DI: 00840194462846 · Model: NS-DF2B-0102 · ORTHOPEDIATRICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Dynamic Femur Fracture Brace
Primary DI
00840194462846
Version / Model
NS-DF2B-0102
Catalog Number
NS-DF2B-0102
Company Name
ORTHOPEDIATRICS CORP.
Labeler DUNS
796416191
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-25
Public Version
1
Public Version Date
2023-07-03
Public Version Status
New
Public Device Record Key
07c4e79c-ced3-462d-aeb5-6a4ec6ab8d6e

Device Description

S DF2 Femur Fracture Brace, Right, Static Knee

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
MR Unsafe
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
No

Product Codes

Code Name
IQI ORTHOSIS, LIMB BRACE

GMDN Terms

Code Name
66085 Multiple-joint lower limb orthosis

Identifiers

Type ID
Primary 00840194462846