FDA UDI
In Commercial Distribution
🇺🇸 United States
Single-use Fine Needle Biopsy (FNB) Device NA-U210H
DI: 04953170459207
·
Model: NA-U210H-8019
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single-use Fine Needle Biopsy (FNB) Device NA-U210H
- Primary DI
- 04953170459207
- Version / Model
- NA-U210H-8019
- Catalog Number
- N6221130
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-02
- Public Version
- 1
- Public Version Date
- 2025-12-10
- Public Version Status
- New
- Public Device Record Key
- 78e5a20f-6a6e-417f-8ec6-3b6ca4ca7d1c
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 |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 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 | 14953170459204 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 04953170459207 | GS1 | ||||
| Package | 54953170459202 | GS1 | 9 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252646 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 19 | Gauge |