FDA UDI
In Commercial Distribution
🇺🇸 United States
ACN™ Biopsy Needle
DI: 00886333007233
·
Model: ACN1830MF
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ACN™ Biopsy Needle
- Primary DI
- 00886333007233
- Version / Model
- ACN1830MF
- Catalog Number
- ACN1830MF
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c2d06bda-508f-4e7e-8610-13b127f9dabf
Device Description
ACN™ Biopsy Needle 18ga x 30cm
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
- 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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47540 | Soft-tissue biopsy needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20886333007237 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00886333007233 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974446 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 18ga x 30cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry and away from sunlight