Home GUDID 00816287020101 iovera Smart Tip
Primary DI 00816287020101
Brand iovera Smart Tip
Company PACIRA CRYOTECH, INC.
Model STT0811-5
Device description SMART TIP, STIMULATING (1X90MM), 5-PACK
Published 2023-06-15
Public version status New
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 ETN Stimulator, Nerve
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETN Stimulator, Nerve Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816287020118 Primary GS1 0 00816287020101 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816287020118 00816287020118 816287020118 0816287020118 00816287020101 00816287020101 816287020101 0816287020101
GMDN Terms# Term, Definition table Term Definition Hand-held cryosurgical system handpiece tip A sterile component of a hand-held cryosurgery system intended to be attached to the system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin/subcutaneous tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 799347229 Device count 5 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 true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08681823002772 Bioscope Neuromonitor Device BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETI ETN 2026-06-03 20199150023862 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 20199150023879 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 20199150023886 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 B006NVHS102 NONE Neurovision Medical Products, Inc. ETN 2025-12-18 B006HGELS102 NONE Neurovision Medical Products, Inc. ETN 2025-02-12 B006NVPS2 Nerveäna+® Neurovision Medical Products, Inc. ETN 2025-02-11 20763000842547 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 20763000842554 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 20763000842561 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 10887482176853 Bovie ASPEN SURGICAL PRODUCTS, INC. ETN 2024-08-27 08720791376451 Technomed Europe Technomed Engineering B.V. ETN 2024-05-06 08720791376475 Technomed Europe Technomed Engineering B.V. ETN 2024-05-06 08720791376482 Technomed Europe Technomed Engineering B.V. ETN 2024-05-06 08720791373634 Neuroradium Technomed Engineering B.V. ETN 2024-02-12 08720791373665 Neuroradium Technomed Engineering B.V. ETN 2024-02-12 B006NVPTKITC3P6WSF52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITC3P7WSF52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITC3P8WSF52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCLD52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCLWF52 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCSD52 Nerveana+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPTKITDCSWF52 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPMK1 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPSTST2 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPT1 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006NVPUSB1 Nerveäna+® Neurovision Medical Products, Inc. ETN 2024-02-01 B006IDKWSF51252 Scorpion Neurovision Medical Products, Inc. ETN 2023-09-01 B006NVPTKITC3P652 Nerveana+® Neurovision Medical Products, Inc. ETN 2023-04-20 B006NVPTKITC3P6T52 Nerveana+® Neurovision Medical Products, Inc. ETN 2023-04-20