AccessGUDID - DEVICE: Guenter Bissinger Medizintechnik GmbH (04250418740678)

GUDID

Device Identifier (DI) Information

Brand Name: Guenter Bissinger Medizintechnik GmbH
Version or Model: 82460302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82460302
Company Name: Günter Bissinger Medizintechnik GmbH

Primary DI Number: 04250418740678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 326515533 *Terms of Use

Device Description: POWERGRIP 3.0 MICRO bipolar electrode Ø 3 mm, working length 29 cm Dissector Maryland

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:	No
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?
32684	Endoscopic electrosurgical handpiece/electrode, bipolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, electrosurgical, endoscopic (with or without 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 8157781d-ccd5-4982-a406-271fd4828066
Public Version Date: March 31, 2020
Public Version Number: 1
DI Record Publish Date: March 23, 2020