Identity
- Trade Name
- 13G Tuohy Needle 6" FDA UDI
- Generic Name
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- 13G Tuohy Needle 6" FDA UDI
- Model / Reference
- MD0532-A FDA UDI
- Description
- 13G Tuohy Needle 6" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859619004646 FDA UDI
- 510(k) Number
- K180981 FDA UDI
- FDA Product Code
- GZB FDA UDI
- GMDN Term
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 15.24 Centimeter FDA UDILength — 6 Inch FDA UDI
Category: Neurosurgical procedure kit, non-medicated, single-use
13G Tuohy Needle 6" by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurosurgical procedure kit, non-medicated, single-use.
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Cleared under the same submission
K180981 also covers:
- 13G Tuohy Needle 4.5" — STIMWAVE TECHNOLOGIES INCORPORATED
- Guidewire 3-Pack — STIMWAVE TECHNOLOGIES INCORPORATED
- Introducer 6" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- Large Antenna 30" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- RF Stylet — STIMWAVE TECHNOLOGIES INCORPORATED
- SeaSilk Antenna Large 28" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- SeaSilk Antenna Large 30" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- SeaSilk Antenna Small 12" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- SeaSilk Antenna Small 27" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- Small Antenna 12" Length — STIMWAVE TECHNOLOGIES INCORPORATED
- Small Antenna 27" Length — STIMWAVE TECHNOLOGIES INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stimwave Technologies Incorporated
Sources (1)
- FDA UDI 5620bac0-022d-4d8c-9b26-77db3f0dc1a6 36 fields · synced May 30, 2026