AccessGUDID - DEVICE: 1300XSB (00852350007006)

GUDID

Device Identifier (DI) Information

Brand Name: 1300XSB
Version or Model: 1300XSB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03-1300XSB
Company Name: ISOLUX LLC

Primary DI Number: 00852350007006
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 828730973 *Terms of Use

Device Description: 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.

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?
35158	Endoscopic light source unit, line-powered	A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022384	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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f61010eb-05d9-4be9-894a-9426a2b6d8af
Public Version Date: December 22, 2021
Public Version Number: 5
DI Record Publish Date: December 01, 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
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: 239-514-7475
Email: nick@isoluxllc.com

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