FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoMagic
DI: B3393000080
·
Model: 300-008
·
Neo Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NeoMagic
- Primary DI
- B3393000080
- Version / Model
- 300-008
- Catalog Number
- 300-008
- Company Name
- Neo Medical Inc.
- Labeler DUNS
- 015510540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2025-07-22
- Public Version Status
- Update
- Public Device Record Key
- 35d3710c-5f83-4435-b173-b241685e2af4
Device Description
3.0Fr x 10cm IR Introducer Seldinger 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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| KZH | Introducer, Syringe Needle | General Hospital | 880.6920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B3393000085 | HIBCC | Case | 5 | In Commercial Distribution | |
| Primary | B3393000080 | HIBCC |
Customer Contacts
- Phone
- 888-450-3334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951384 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10.0 | Centimeter | |
| Catheter Gauge | 3.0 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry