AccessGUDID - DEVICE: ABC® Bend-A-Beam® (30653405002745)

GUDID

Device Identifier (DI) Information

Brand Name: ABC® Bend-A-Beam®
Version or Model: 134003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 134003
Company Name: Conmed Corporation

Primary DI Number: 30653405002745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 10653405002741

Device Description: ABC® Bend-A-Beam® Handpiece Handcontrol Malleable Handpiece, 3" (7.6 cm)

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):	Yes
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?
62982	Inert gas-enhanced open-surgery electrosurgical handpiece/electrode	An invasive, rigid, hand-held component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation during open surgery. It is a handpiece with an included electrode typically in the form of a pen with controls (or controlled via a foot-switch). It includes a coaxial arrangement of a monopolar electrode within a gas delivery sleeve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & 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
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Humidity: between 5 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78ceba3e-5f36-4e39-b1e7-62d5e5989dc6
Public Version Date: August 01, 2024
Public Version Number: 5
DI Record Publish Date: December 01, 2023