Identity
- Trade Name
- Walcott Rx FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Tungsten Microdissection Needle 2" (5.1cm), Insulated, Straight FDA UDI
- Model / Reference
- RX30-8008 FDA UDI
- Description
- Tungsten Microdissection Needle 2" (5.1cm), Insulated, Straight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019110010 FDA UDI
- 510(k) Number
- K895331 FDA UDI
- FDA Product Code
- JOS FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 2 Inch FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Walcott Rx by Walcott Rx Product Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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Cleared under the same submission
K895331 also covers:
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
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
- Walcott Rx Product Inc
Sources (1)
- FDA UDI 8b3e47d1-3d4c-4ff3-9c25-07f18a69f0ea 36 fields · synced Jun 8, 2026