AccessGUDID - DEVICE: ABC® Bend-A-Beam® (10653405002765)

GUDID

Device Identifier (DI) Information

Brand Name: ABC® Bend-A-Beam®
Version or Model: 134009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 134009
Company Name: Conmed Corporation

Primary DI Number: 10653405002765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ABC® Bend-A-Beam® Handpiece Handcontrol Malleable Handpiece, 9" (22.8 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":	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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 9 Inch
Length: 22.8 Centimeter

Device Record Status

Public Device Record Key: 007912db-6183-4fdb-a213-2f8d550beb34
Public Version Date: August 01, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20653405002762	10	10653405002765		In Commercial Distribution	BOX

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00653405002768 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(866)426-6633
Email: CustomerExperience@conmed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES