AccessGUDID - DEVICE: Rechargeable Light Source (00714646001375)

GUDID

Device Identifier (DI) Information

Brand Name: Rechargeable Light Source
Version or Model: 3600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3600
Company Name: Bionix, LLC

Primary DI Number: 00714646001375
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 117844489 *Terms of Use

Device Description: Rechargeable Light Source with Magnification Lens

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?
65447	ENT instrument light source	An electrically-powered, noninvasive device intended to be attached to the proximal end of an appropriate ear/nose/throat (ENT) instrument (e.g., curette or forceps) [not included] to produce light and facilitate visualization. It is designed for use with an instrument with light transmitting features; it is not intended for endoscopic use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYT	LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48458b23-6ee7-47f7-953e-ee1288b8205f
Public Version Date: March 14, 2025
Public Version Number: 2
DI Record Publish Date: February 25, 2025

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: 10714646001372 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)551-7096
Email: Bionix@bionix.com

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