FDA UDI
In Commercial Distribution
🇺🇸 United States
Zutron Medical
DI: 00817658020188
·
Model: ZUTR162000
·
ZUTRON MEDICAL, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zutron Medical
- Primary DI
- 00817658020188
- Version / Model
- ZUTR162000
- Catalog Number
- ZUTR162000
- Company Name
- ZUTRON MEDICAL, L.L.C.
- Labeler DUNS
- 962532441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8a5efee5-d1c7-4a08-8ee3-df7a7adca808
Device Description
The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope Stiffening Device.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "High-level Disinfectant", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17826 | Colonoscope stiffener | A dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817658020188 | GS1 |