FDA UDI In Commercial Distribution 🇺🇸 United States

Electrode Delivery Tool Kit MedCoat, CE

DI: 00852184003373 · Model: 22-0018 · Synapse Biomedical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Electrode Delivery Tool Kit MedCoat, CE
Primary DI
00852184003373
Version / Model
22-0018
Company Name
Synapse Biomedical, Inc.
Labeler DUNS
138432070
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
e7eb9539-b463-4088-8819-1ca81a324d0e

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
Yes
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
OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

GMDN Terms

Code Name
47808 Intramuscular diaphragm/phrenic nerve electrical stimulation system

Identifiers

Type ID
Primary 00852184003373