FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cytology Brush
DI: 00816207020532
·
Model: CB-1615
·
ENDO-THERAPEUTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cytology Brush
- Primary DI
- 00816207020532
- Version / Model
- CB-1615
- Catalog Number
- CB-1615
- Company Name
- ENDO-THERAPEUTICS, INC.
- Labeler DUNS
- 825239189
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 00621c57-bc31-4502-8561-2985877bb020
- Distribution End Date
- 2019-11-04
Device Description
Flexible endoscopic cytology brush
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
- 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 |
|---|---|---|---|---|
| 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 | 10816207020539 | GS1 | box | 10 | Not in Commercial Distribution | 2019-11-04 |
| Primary | 00816207020532 | GS1 |
Customer Contacts
- Phone
- 844-400-3636
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800966 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Brush Diameter 3.0 mm | ||
| Device Size Text, specify | Min Channel 2.8 mm | ||
| Outer Diameter | 2.4 | Millimeter | |
| Length | 150 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry