AccessGUDID - DEVICE: Rev360 (07613327055597)

GUDID

Device Identifier (DI) Information

Brand Name: Rev360
Version or Model: 0504990800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0504-990-800
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327055597
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: [Collings Knife Electrode, 22 Fr., Only for use with Stryker Resectoscopes, Do not use if package is damaged]

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":	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?
61872	Endoscopic electrosurgical electrode, bipolar, single-use	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAJ	Cystoscope and accessories, flexible/rigid
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
KQT	Evacuator, gastro-urology
HIH	HYSTEROSCOPE (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 5c63b034-8f60-41ac-88c4-0da3840cd18d
Public Version Date: September 04, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2016