FDA UDI In Commercial Distribution 🇺🇸 United States

PeroSupport.tec

DI: 04048817378789 · Model: 197R4/R3 · Streifeneder ortho.production GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PeroSupport.tec
Primary DI
04048817378789
Version / Model
197R4/R3
Catalog Number
197R4/R3
Company Name
Streifeneder ortho.production GmbH
Labeler DUNS
317931954
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-15
Public Version
3
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
232d57ff-1be3-461b-a538-9fa4f3a0c9da

Device Description

PeroSupport.tec, peroneal spring made of carbon-pre-preg, dynamic, with magnetic closure, shoe size: 42-45, right

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
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
OHI Orthosis, Foot Drop

GMDN Terms

Code Name
36206 Ankle/foot orthosis

Identifiers

Type ID
Primary 04048817378789