FDA UDI
In Commercial Distribution
🇺🇸 United States
Cellebrity
DI: 08714729746249
·
Model: M00516010
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cellebrity
- Primary DI
- 08714729746249
- Version / Model
- M00516010
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 29f4d00a-7315-4984-abbd-164766ad9cd1
Device Description
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
- 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 |
|---|---|---|---|---|
| BTG | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) | Ear, Nose, Throat | 874.4680 | 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 |
| 46388 | General-purpose cytology brush | A sterile device consisting of tufts or bristles set into a handle that is intended to collect cells from an area of the body, typically during an open surgical procedure. The cells are used for histopathological analysis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729138990 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08714729746249 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 140 cm Effective Length | ||
| Device Size Text, specify | 1.5 mm Diameter |