FDA UDI In Commercial Distribution 🇺🇸 United States

PELLEVE S5

DI: 00841494104207 · Model: IEC5P-ST/110-USA · Cynosure, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PELLEVE S5
Primary DI
00841494104207
Version / Model
IEC5P-ST/110-USA
Catalog Number
IEC5P-ST/110-USA
Company Name
Cynosure, LLC
Labeler DUNS
780318028
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
4
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
75397bf5-c2a4-4479-85e4-ce0f2a223626

Device Description

PELLEVE S5 GENERATOR, 110 USA

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
44776 Electrosurgical system

Identifiers

Type ID
Primary 00841494104207