FDA UDI
In Commercial Distribution
🇺🇸 United States
Hawkins™ Blunt Needle
DI: 00886333003532
·
Model: 218207
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hawkins™ Blunt Needle
- Primary DI
- 00886333003532
- Version / Model
- 218207
- Catalog Number
- 218207
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7aba703a-f9cd-47b9-ab1f-0b7e93ff9ffc
Device Description
Hawkins™ Blunt Needle 18ga x 20cm
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 |
|---|---|---|---|---|
| 46234 | Closed-wound drainage kit, micro-drainage | A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for atraumatic over-the-wire placement of the catheter. The initial puncture is made with the needle, the guidewire is advanced through the needle, which is then removed, and the catheter/dilator is advanced over the guidewire to obtain access to the site. The kit may have a wide range of surgical applications (e.g., general and plastic surgery). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20886333003536 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00886333003532 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 18ga x 20cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry and away from sunlight