FDA UDI
In Commercial Distribution
🇺🇸 United States
WaveSelect
DI: 06945258302107
·
Model: GW1010
·
Enlight Medical Technologies(Shenzhen) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WaveSelect
- Primary DI
- 06945258302107
- Version / Model
- GW1010
- Company Name
- Enlight Medical Technologies(Shenzhen) Co., Ltd.
- Labeler DUNS
- 545380342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-31
- Public Version
- 1
- Public Version Date
- 2025-08-08
- Public Version Status
- New
- Public Device Record Key
- 00c960ba-43b0-4416-8d47-56d22c11b669
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | Cardiovascular | 870.1330 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06945258302107 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240871 | 000 |