FDA UDI In Commercial Distribution 🇺🇸 United States

East Coast Surgical Instruments

DI: 00850837007136 · Model: 14-8100 · East Coast Surgical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
East Coast Surgical Instruments
Primary DI
00850837007136
Version / Model
14-8100
Company Name
East Coast Surgical Inc.
Labeler DUNS
009464582
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-08-24
Public Version
3
Public Version Date
2019-02-21
Public Version Status
Update
Public Device Record Key
b171a819-5522-409d-8952-578f18ac8bd9

Device Description

Needle Tip Electrode 32cm

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
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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

GMDN Terms

Code Name
58039 Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Identifiers

Type ID
Primary 00850837007136