FDA UDI
In Commercial Distribution
🇺🇸 United States
WANG
DI: 20653405052699
·
Model: SW-221
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- WANG
- Primary DI
- 20653405052699
- Version / Model
- SW-221
- Catalog Number
- SW-221
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d9ebae94-ead1-4a45-a243-74f564959cf9
Device Description
WANG TRANSBRONCHIAL CYTOLOGY NEEDLE
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 |
|---|---|---|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38825 | General-purpose endoscopic needle, single-use | A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10653405052692 | GS1 | BOX | 4 | In Commercial Distribution | |
| Primary | 20653405052699 | GS1 | ||||
| Unit of Use | 00653405052695 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914181 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.9 | Millimeter | |
| Length | 15 | Millimeter | |
| Length | 130 | Centimeter | |
| Weight | 21 | Gram |