FDA UDI
In Commercial Distribution
🇺🇸 United States
Triple-Loop Snare Retrieval Kit
DI: 00886333224616
·
Model: 380911330
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Triple-Loop Snare Retrieval Kit
- Primary DI
- 00886333224616
- Version / Model
- 380911330
- Catalog Number
- 380911330
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-16
- Public Version
- 1
- Public Version Date
- 2021-06-24
- Public Version Status
- New
- Public Device Record Key
- 77fd2414-5312-41ed-8b1d-5e18e9f5a577
Device Description
Triple-Loop Snare Retrieval Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45162 | Vena cava filter extraction/repositioning kit | A collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886333224616 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191758 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and away from sunlight