FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Angulation Knob Extender
DI: 06936603228937
·
Model: FTL-DEK-A
·
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single Use Angulation Knob Extender
- Primary DI
- 06936603228937
- Version / Model
- FTL-DEK-A
- Catalog Number
- MAJ-2219
- Company Name
- Yangzhou Fartley Medical Instrument Technology Co., Ltd
- Labeler DUNS
- 544375774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-03
- Public Version
- 1
- Public Version Date
- 2025-12-11
- Public Version Status
- New
- Public Device Record Key
- 22872a86-d8e8-448a-b11a-e2cd6717170c
Device Description
For Olympus 160/180/190 series endoscopes For OLYMPUS EVIS EXERA (160 series), EXERA II (180 series), and EXERA Ill (190 series) endoscopes except CF-2T160, GIF-2T160, and GIF-2TH180
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65126 | Surgical instrument handle grip | A device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16936603228934 | GS1 | Sales Packaging | 10 | In Commercial Distribution | |
| Primary | 06936603228937 | GS1 | ||||
| Package | 26936603228931 | GS1 | Shipping Carton | 10 | In Commercial Distribution |