AccessGUDID - DEVICE: NEUWAVE (00818913020516)

GUDID

Device Identifier (DI) Information

Brand Name: NEUWAVE
Version or Model: RCPK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RCPK
Company Name: NEUWAVE MEDICAL, INC.

Primary DI Number: 00818913020516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809758878 *Terms of Use

Device Description: Surgical Clip, Dual, 15ga or 17ga Probe, 5 Pack

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?
64048	Microwave ablation system probe planar-coagulation guide	A sterile surgical device designed to hold two or more microwave ablation probes together in a parallel configuration in order to facilitate planar coagulation of soft tissue prior to resection. It is a plastic device which fastens onto the hand-held probes to position them for the planar coagulation procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200081	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e1f7986-5ac8-4d12-918b-166a6302120c
Public Version Date: May 06, 2021
Public Version Number: 1
DI Record Publish Date: April 28, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00818913020523	5	00818913020516		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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(877)323-9283
Email: info@neuwave.com

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