FDA UDI In Commercial Distribution 🇺🇸 United States

Non-Telescopic PenEvac

DI: 00817688022602 · Model: ICM-000-0580 · I.C. MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Non-Telescopic PenEvac
Primary DI
00817688022602
Version / Model
ICM-000-0580
Catalog Number
ICM-000-0580
Company Name
I.C. MEDICAL, INC.
Labeler DUNS
616182895
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-03-29
Public Version
1
Public Version Date
2019-04-08
Public Version Status
New
Public Device Record Key
20e1abec-bd6c-4992-8d77-a9c0164bf1fd

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
61869 Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Identifiers

Type ID
Package 00817688022619
Primary 00817688022602