FDA UDI In Commercial Distribution 🇺🇸 United States

EXTRA-LARGE GROUNDING PAD, 25 PCS

DI: 10841494108431 · Model: MEL-01221 · Cynosure, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
EXTRA-LARGE GROUNDING PAD, 25 PCS
Primary DI
10841494108431
Version / Model
MEL-01221
Company Name
Cynosure, LLC
Labeler DUNS
780318028
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2020-01-31
Public Version
2
Public Version Date
2023-01-11
Public Version Status
Update
Public Device Record Key
0e854408-e1a4-4d96-800c-1a4ea6c53bad

Device Description

EXTRA-LARGE GROUNDING PAD, 25 PCS

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
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
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
ODR Electrosurgical patient return electrode

GMDN Terms

Code Name
11500 Electrosurgical return electrode, single-use, sterile

Identifiers

Type ID
Primary 10841494108431
Unit of Use 00841494108434

Premarket Submissions

Submission Number Supplement Number
K190678 000