FDA UDI In Commercial Distribution 🇺🇸 United States

ri-former® diagn. station for rail, 2 handles, 3,5V / 230V, without clamp

DI: 04045396189126 · Model: 3652-400 · Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ri-former® diagn. station for rail, 2 handles, 3,5V / 230V, without clamp
Primary DI
04045396189126
Version / Model
3652-400
Catalog Number
3652-400
Company Name
Rudolf Riester GmbH
Labeler DUNS
537208717
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-31
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
59cddb13-12d3-4139-9a5a-e157c92ca688

Device Description

Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis.

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
No
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
HLJ Ophthalmoscope, Battery-Powered

GMDN Terms

Code Name
11585 ENT examination/treatment system

Identifiers

Type ID
Primary 04045396189126

Premarket Submissions

Submission Number Supplement Number
K950914 000