Avecure MWG881

GUDID 00858584002084

Microwave Ablation/Coagulation Generator

MEDWAVES, INC.

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Primary Device ID	00858584002084
NIH Device Record Key	813a8e07-79ca-4233-8fbd-54771daa8d27
Commercial Distribution Status	In Commercial Distribution
Brand Name	Avecure
Version Model Number	MWG881
Catalog Number	MWG881
Company DUNS	122915353
Company Name	MEDWAVES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858584002084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143203

FDA Product Code

NEY	System, Ablation, Microwave And Accessories

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-28

On-Brand Devices [Avecure]

00858584002220	16Gauge, Large Antenna Probe, 50cm length
00858584002213	14Gauge, Medium Antenna Probe, 20cm length
00858584002206	16Gauge, Large Antenna Probe, 15cm length
00858584002190	14Gauge, Large Antenna Probe, 30cm length
00858584002183	16Gauge, Small Antenna Probe, 21cm length
00858584002176	16Gauge, Small Antenna Probe, 158cm length
00858584002169	16Gauge, Small Antenna Probe, 90cm length
00858584002152	16Gauge, Small Antenna Probe, 10cm length
00858584002145	14Gauge, Large Antenna Probe, 23cm length
00858584002138	14Gauge, Medium Antenna Probe, 15cm length
00858584002114	Extension Cable Set (8 ft.)
00858584002091	14Gauge, Large Antenna Probe, 20cm length
00858584002084	Microwave Ablation/Coagulation Generator
00858584002077	16Gauge, Mini Antenna Probe, 15cm length
00858584002053	16Gauge, Small Antenna Probe, 15cm length
00858584002022	14Gauge, Large Antenna Probe, 23cm length
00858584002008	14Gauge, Large Antenna Probe, 15cm length