FDA.report

OtoClear® Spray Wash, Sample

Primary DI
00714646000767
Brand
OtoClear® Spray Wash, Sample
Company
Bionix, LLC
Model
27295
Catalog number
27295
Device description
Sample, Spraywash
Published
2022-01-07
Public version status
New
Distribution status
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
KCPSYRINGE, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00714646000767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000767007146460007677146460007670714646000767

GMDN Terms

TermDefinition
Ear canal irrigation kit, reusableA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
117844489
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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