FDA UDI
In Commercial Distribution
🇺🇸 United States
Typenex Introducer Set
DI: 00810050855808
·
Model: MS2335S
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Typenex Introducer Set
- Primary DI
- 00810050855808
- Version / Model
- MS2335S
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-17
- Public Version
- 1
- Public Version Date
- 2025-11-25
- Public Version Status
- New
- Public Device Record Key
- 64a42f5a-1fa2-4f98-8edc-b7a85205c7e5
Device Description
Micro Introducer: 4F x 20cm, Smooth Tip Needle, 0.018 Nitinol/AU Wire, Stiffen Dilator
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
- Yes
- 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 |
|---|---|---|---|---|
| OFL | Percutaneous Sheath Introducer Kit | Cardiovascular | 870.1340 | 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 | 10810050855805 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00810050855808 | GS1 | ||||
| Package | 20810050855802 | GS1 | Shipper | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 20 | Centimeter | |
| Catheter Inner Diameter | 1.333 | Millimeter |