FDA UDI Not in Commercial Distribution 🇺🇸 United States

Flexible Video Esophagoscope (NTSC) Reconditioned

DI: 00874485002879 · Model: TNE-5000 · COGENTIX MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Flexible Video Esophagoscope (NTSC) Reconditioned
Primary DI
00874485002879
Version / Model
TNE-5000
Catalog Number
03-5201P
Company Name
COGENTIX MEDICAL, INC.
Labeler DUNS
780024725
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-22
Public Version
5
Public Version Date
2023-02-03
Public Version Status
Update
Public Device Record Key
8d293573-607d-41f5-99b3-5fea3dcd9534
Distribution End Date
2018-07-26

Device Description

Reconditioned

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
High-level Disinfectant

Product Codes

Code Name
EOX Esophagoscope (Flexible Or Rigid)

GMDN Terms

Code Name
17662 Flexible video bronchoscope, reusable

Identifiers

Type ID
Primary 00874485002879

Customer Contacts

Phone
866-258-2182