FDA.report

Rechargeable Light Source

Primary DI
00714646001375
Brand
Rechargeable Light Source
Company
Bionix, LLC
Model
3600
Catalog number
3600
Device description
Rechargeable Light Source with Magnification Lens
Published
2025-02-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KYTLIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00714646001375PrimaryGS10
10714646001372Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646001375007146460013757146460013750714646001375
1071464600137210714646001372

GMDN Terms

TermDefinition
ENT instrument light sourceAn 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.

Contacts

PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags

DUNS number
117844489
Device count
2
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00714646001511Pelvis Belly Replacement Stomach Cushion - SmallPPRT-5108PPRT-51082025-08-21
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00714646001405Prone Breast, Arm Rest, ReplacementPBRT-6255PBRT-62552025-05-28
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00714646001429Prone Breast, Hand Post Assembly, ReplacementPBRT-6300PBRT-63002025-05-28

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