FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER
DI: 00884908029680
·
Model: MC62
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER
- Primary DI
- 00884908029680
- Version / Model
- MC62
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-02
- Public Version
- 5
- Public Version Date
- 2024-06-06
- Public Version Status
- Update
- Public Device Record Key
- d6728ee3-1379-4c5b-8475-c8b0c5458379
- Distribution End Date
- 2020-12-07
Device Description
18GA X 7CM ONE-PART18GA X 7CM ON COURNAND NEEDLECOURNAND NEEDLE
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
- 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 |
|---|---|---|---|---|
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61502 | Vascular catheter introduction needle | A sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50884908029685 | GS1 | box | 20 | Not in Commercial Distribution | 2020-12-07 |
| Primary | 00884908029680 | GS1 |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K851834 | 000 |