Home GUDID 10607151010833 BOVIE
Primary DI 10607151010833
Brand BOVIE
Company BOVIE MEDICAL CORPORATION
Model BA3350NA
Catalog number BA3350NA
Device description DISPOSABLE BIPOLAR ABLATOR, 3.3MM, 55°, NON-ASPIRATING
Published 2016-10-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GEI Electrosurgical, Cutting & Coagulation & Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10607151010833 Package GS1 1 In Commercial Distribution 00607151010836 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10607151010833 10607151010833 00607151010836 00607151010836 607151010836 0607151010836
GMDN Terms# Term, Definition table Term Definition Endoscopic electrosurgical handpiece/electrode, bipolar, single-use A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 079940465 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776429140 Millennium Avalign Technologies, Inc. GEI 2026-09-04 00840113233281 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233304 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233328 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233342 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233366 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233380 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233403 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233427 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233441 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233465 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233489 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233502 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233526 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237326 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237340 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237593 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237623 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237661 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237692 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00190776428006 Millennium Avalign Technologies, Inc. GEI 2026-08-27 00190776428037 Millennium Avalign Technologies, Inc. GEI 2026-08-27 B4193533010 Maxtown Medical Modern Surgical Instruments LLC GEI 2026-08-27 ESUMARS980010 Sutter Sutter Medizintechnik GmbH GEI 2026-08-27 00190776427436 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427542 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427573 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427672 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427689 Millennium Avalign Technologies, Inc. GEI 2026-08-26 B108890POAMUS00 BTL-890U BTL INDUSTRIES LIMITED GEI 2026-08-26