FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short
DI: 00854172008124
·
Model: 3.2-EPR-COL-O
·
INTERSCOPE, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short
- Primary DI
- 00854172008124
- Version / Model
- 3.2-EPR-COL-O
- Catalog Number
- 3.2-EPR-COL-O
- Company Name
- INTERSCOPE, INC
- Labeler DUNS
- 968227913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-06
- Public Version
- 1
- Public Version Date
- 2021-04-14
- Public Version Status
- New
- Public Device Record Key
- 7780ea5f-fdcd-4e1d-8532-b3669c5408c3
Device Description
EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Colonoscope Short Olympus
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTE | Endoscopic Morcellator Gastroenterology | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46732 | Tissue morcellation system handpiece, line-powered | A hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854172008124 | GS1 |
Customer Contacts
- Phone
- 1-800-461-4289
- [email protected]