FDA UDI
In Commercial Distribution
🇺🇸 United States
swiftMATCH Coil, Soft
DI: 00810169722183
·
Model: 400SWSFT410-A
·
PENUMBRA, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- swiftMATCH Coil, Soft
- Primary DI
- 00810169722183
- Version / Model
- 400SWSFT410-A
- Catalog Number
- 400SWSFT410
- Company Name
- PENUMBRA, INC.
- Labeler DUNS
- 191077671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-26
- Public Version
- 1
- Public Version Date
- 2026-02-03
- Public Version Status
- New
- Public Device Record Key
- c399fd77-4a67-4301-8f00-8b4da6db16e4
Device Description
swiftMATCH Coil, Soft, 4mm x 10cm
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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | Neurology | 882.5950 | 2 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60940 | Neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. | Yes | Active |
| 60941 | Non-neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810169722183 | GS1 |
Customer Contacts
- Phone
- 1-888-272-4606
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230284 | 000 |