FDA UDI
In Commercial Distribution
🇺🇸 United States
MT
DI: 06932503549059
·
Model: CYB-30S-24C
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MT
- Primary DI
- 06932503549059
- Version / Model
- CYB-30S-24C
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-31
- Public Version
- 1
- Public Version Date
- 2022-01-10
- Public Version Status
- New
- Public Device Record Key
- 2464d1dc-2373-42ab-b6d1-3e183c8a1ba3
Device Description
With sheath, 3 mm brush head, diameter of sheath 2.3 mm, working length 2400 mm
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDX | Endoscopic Cytology Brush | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38834 | Flexible endoscopic cytology brush, single-use | A device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16932503549056 | GS1 | box | 20 | In Commercial Distribution | |
| Primary | 06932503549059 | GS1 | ||||
| Package | 26932503549053 | GS1 | case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172663 | 000 |