FDA UDI In Commercial Distribution 🇺🇸 United States

Push braces

DI: 08715669009395 · Model: 3.10.3.11 · Nea International B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Push braces
Primary DI
08715669009395
Version / Model
3.10.3.11
Company Name
Nea International B.V.
Labeler DUNS
410032197
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-03
Public Version
1
Public Version Date
2025-01-13
Public Version Status
New
Public Device Record Key
c2fb2142-00cb-4b97-9f67-b5f61d527d52

Device Description

Push ortho Hand Orthese DPT Base Part L1

Device Characteristics

Single Use
Yes
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
IQI ORTHOSIS, LIMB BRACE

GMDN Terms

Code Name
41044 Wrist/hand/finger stable-position orthosis

Identifiers

Type ID
Primary 08715669009395

Customer Contacts

Phone
+31434079220