FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Cytology Brush BC-205D
DI: 04953170401961
·
Model: BC-205D-2010
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Single Use Cytology Brush BC-205D
- Primary DI
- 04953170401961
- Version / Model
- BC-205D-2010
- Catalog Number
- N5767440
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-19
- Public Version
- 5
- Public Version Date
- 2024-01-09
- Public Version Status
- Update
- Public Device Record Key
- 186c68bb-9721-4eca-a4d0-0d1e90125930
Device Description
Single Use Cytology Brush BC-205D
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 |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14953170401968 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04953170401961 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]