AccessGUDID - DEVICE: BiPad Hand Activated Disposable Bipolar Electrocautery Cord (00860001107012)

GUDID

Device Identifier (DI) Information

Brand Name: BiPad Hand Activated Disposable Bipolar Electrocautery Cord
Version or Model: BP105-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BP105C
Company Name: Bipad, Inc.

Primary DI Number: 00860001107012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117114183 *Terms of Use

Device Description: BiPad Hand Activated Disposable Bipolar Electrocautery Cord Model BP105-C (Codman version)

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?
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	A sterile rigid combined electrosurgical handpiece and bipolar 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201833	000

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 16 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c70135c-91c1-47c4-96e8-0077aa6afc9f
Public Version Date: October 27, 2020
Public Version Number: 1
DI Record Publish Date: October 19, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10860001107033	1	00860001107012	In Commercial Distribution	Tyvek
00860001107050	20	10860001107033	In Commercial Distribution	Shelf Box
00860001107067	4	00860001107050	In Commercial Distribution	Master Shipping Box