AccessGUDID - DEVICE: Kirwan (00841019107393)

GUDID

Device Identifier (DI) Information

Brand Name: Kirwan
Version or Model: 30-5200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KIRWAN SURGICAL PRODUCTS LLC

Primary DI Number: 00841019107393
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046355210 *Terms of Use

Device Description: Disposable Monopolar Suction Coagulator with Resectoscope Pin, 5.5 in. (14cm) 10 Fr

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
61869	Open-surgery electrosurgical handpiece/electrode, monopolar, single-use	A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAM	Apparatus, Electrosurgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K895337	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 5.5 Inch

Device Record Status

Public Device Record Key: 693c47ce-ecca-4c18-ab16-2b9995a038ed
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: May 04, 2016