FDA UDI
In Commercial Distribution
🇺🇸 United States
ClosureFast Introducer Sheath
DI: 00886333227525
·
Model: IS-7F11
·
ARGON MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ClosureFast Introducer Sheath
- Primary DI
- 00886333227525
- Version / Model
- IS-7F11
- Catalog Number
- IS-7F11
- Company Name
- ARGON MEDICAL DEVICES, INC.
- Labeler DUNS
- 140727624
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 2
- Public Version Date
- 2026-04-17
- Public Version Status
- Update
- Public Device Record Key
- efe9f290-b293-4fb2-8aad-33bb9a0ae1b3
Device Description
ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm
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 |
|---|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | 870.1310 | 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 | 20886333227529 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00886333227525 | GS1 |
Customer Contacts
- Phone
- 1.800.927.4669
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K780126 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | (2.3mm) x 11cm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and away from sunlight