FDA UDI In Commercial Distribution 🇺🇸 United States

ManaEZ Single Panel Knee Immobilizer 18"

DI: 00810113682969 · Model: EZIMM01-18 · Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ManaEZ Single Panel Knee Immobilizer 18"
Primary DI
00810113682969
Version / Model
EZIMM01-18
Catalog Number
EZIMM01-18
Company Name
Manamed, Inc.
Labeler DUNS
084042331
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-11-25
Public Version
2
Public Version Date
2026-02-09
Public Version Status
Update
Public Device Record Key
6a5bd9f9-614e-4792-8eee-2693d4a19e4c

Device Description

The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The combination of the posterior stay and two adjustable lateral stays maintains the optimum leg position. The popliteal pad ensures an intimate fit around the knee joint. Available in 16", 18", 20", and 24" lengths in our single and three-panel design. Ideal for strains and sprains of the knee, stable fractures of the tibia, and patellar tendon repairs.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No

Product Codes

Code Name
IQI Orthosis, Limb Brace

GMDN Terms

Code Name
12099 Knee splint

Identifiers

Type ID
Primary 00810113682969

Customer Contacts

Phone
888-508-0712