FDA UDI
In Commercial Distribution
🇺🇸 United States
Westcott Needle Marked
DI: 00813079021964
·
Model: WNM-2006NS
·
REMINGTON MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
125
Basic Information
- Brand Name
- Westcott Needle Marked
- Primary DI
- 00813079021964
- Version / Model
- WNM-2006NS
- Catalog Number
- WNM-2006NS
- Company Name
- REMINGTON MEDICAL, INC.
- Labeler DUNS
- 788472314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 125
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 1
- Public Version Date
- 2020-10-02
- Public Version Status
- New
- Public Device Record Key
- 388233bb-fb04-4a56-bf85-7d53c576ce3d
Device Description
20ga (0.9mm) x 15cm
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35886 | Body aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813079021961 | GS1 | Shipping Carton | 8 | In Commercial Distribution | |
| Primary | 00813079021964 | GS1 | ||||
| Unit of Use | 80813079021960 | GS1 |
Customer Contacts
- Phone
- +1(800)989-0057
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20 | Gauge |