AccessGUDID - DEVICE: BONSS (06927155386954)

GUDID

Device Identifier (DI) Information

Brand Name: BONSS
Version or Model: BC401
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jiangsu Bonss Medical Technology Co., Ltd.

Primary DI Number: 06927155386954
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543429834 *Terms of Use

Device Description: No description.

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):	No
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?
63308	Electrolytic-plasma electrosurgical system	An assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221743	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2300d024-373a-480e-9d9a-d2adb30be115
Public Version Date: November 11, 2024
Public Version Number: 1
DI Record Publish Date: November 02, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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