FDA UDI In Commercial Distribution 🇺🇸 United States

Mitchell Ponseti® Bracing System

DI: 00810060888605 · Model: PS-LG · MD ORTHOPAEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Mitchell Ponseti® Bracing System
Primary DI
00810060888605
Version / Model
PS-LG
Company Name
MD ORTHOPAEDICS, INC.
Labeler DUNS
146220269
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-15
Public Version
1
Public Version Date
2025-12-23
Public Version Status
New
Public Device Record Key
9bbc0339-f164-4193-9db8-fa06cbd83bfc

Device Description

Large Pressure Saddle

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KNP Orthosis, Corrective Shoe

GMDN Terms

Code Name
36206 Ankle/foot orthosis

Identifiers

Type ID
Primary 00810060888605