FDA UDI In Commercial Distribution 🇺🇸 United States

EndoRotor® Roll Stand

DI: 00854172008049 · Model: ERC 20-04 · INTERSCOPE, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EndoRotor® Roll Stand
Primary DI
00854172008049
Version / Model
ERC 20-04
Catalog Number
ERC 20-04
Company Name
INTERSCOPE, INC
Labeler DUNS
968227913
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-08-19
Public Version
2
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
0df5e9cb-4dff-44c4-9ad0-0950540b0112

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
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PTE Endoscopic Morcellator Gastroenterology

GMDN Terms

Code Name
36069 Freestanding/bed-attached intravenous pole

Identifiers

Type ID
Primary 00854172008049

Customer Contacts