FDA UDI In Commercial Distribution 🇺🇸 United States

E Surgical

DI: 00850053927034 · Model: RB4050A-01 · E Surgical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
E Surgical
Primary DI
00850053927034
Version / Model
RB4050A-01
Catalog Number
RB4050A-01
Company Name
E Surgical, LLC
Labeler DUNS
093415510
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-05-26
Public Version
1
Public Version Date
2024-06-03
Public Version Status
New
Public Device Record Key
f8efcef3-7400-438b-8c5a-9db08565936c

Device Description

4.0MM 50° ASPIRATING ABLATOR

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
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
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
57944 Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

Identifiers

Type ID
Package 10850053927031
Primary 00850053927034