AccessGUDID - DEVICE: Valleylab LS10 (10884521512801)

GUDID

Device Identifier (DI) Information

Brand Name: Valleylab LS10
Version or Model: VLLS10GEN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521512801
Issuing Agency: GS1
Commercial Distribution End Date: May 09, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: LS Series Single Channel Vessel Sealing Generator

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:	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?
11490	Electrosurgical system generator	An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-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 [?]
K143654	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -22 and 149 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 25 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 240 V;

Device Record Status

Public Device Record Key: a0f8ca89-f23b-4ef2-8512-4d299e4b4a78
Public Version Date: June 24, 2025
Public Version Number: 12
DI Record Publish Date: March 18, 2018

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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