Identity
- Trade Name
- Surg-e Pak FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Model / Reference
- SP-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846338003982 FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- 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
No
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
No
FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Surg-e Pak by Elliquence Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
- PlasmaBlade™ — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr — KIRWAN SURGICAL PRODUCTS LLC · Class IIb
- Valleylab — Covidien LP · Class II
- A&E Medical / Disposable Suction Coagulator — A & E MEDICAL CORPORATION · Class II
- PlasmaBladeTM — MEDTRONIC NAVIGATION, INC. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elliquence Llc
Sources (1)
- FDA UDI 0c730eea-ff41-41e1-9de1-cf6cf25d7512 32 fields · synced May 30, 2026