FDA UDI In Commercial Distribution 🇺🇸 United States

ManaMed

DI: 00810113680255 · Model: ManaEZ Soft Collar Uni · Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ManaMed
Primary DI
00810113680255
Version / Model
ManaEZ Soft Collar Uni
Catalog Number
EZ120
Company Name
Manamed, Inc.
Labeler DUNS
084042331
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-20
Public Version
2
Public Version Date
2024-07-11
Public Version Status
Update
Public Device Record Key
ff0c3e66-c080-4715-925b-6d38cd858fd5

Device Description

ManaEZ Soft Collar Universal provides uniform support, comfort, and support of the cervical spine. Universally sized Medium density foam

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
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
No

Product Codes

Code Name
IQK Orthosis, Cervical

GMDN Terms

Code Name
41039 Cervical spine collar, reusable

Identifiers

Type ID
Primary 00810113680255