AccessGUDID - DEVICE: NanoKnife (H787204001110)

GUDID

Device Identifier (DI) Information

Brand Name: NanoKnife
Version or Model: 20400111
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANGIODYNAMICS, INC.

Primary DI Number: H787204001110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079105071 *Terms of Use

Device Description: NanoKnife Disposable Single Electrode 5 Probe Pack - Activation

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58836	Irreversible electroporation system	A mobile assembly of devices designed to apply a series of microsecond electrical pulses to tissue to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. The system typically consists of both a mains electricity (AC-powered) computerized current generator with user interface and controls (e.g., foot-switch), and additional necessary components such as electrocardiogram (ECG) trigger monitor and sterile needle-like electrode probes. It is intended for the nonthermal surgical ablation of soft-tissues (e.g., tumours, endothelium).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAB	Low energy direct current thermal ablation system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150089	000
K183385	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Centimeter

Device Record Status

Public Device Record Key: 584fab7b-07ed-4898-ba6c-71458927925d
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
GS1	15051684029643

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(518)795-1676
Email: dgreer@angiodynamics.com

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