FDA.report

OTOCELL® Ear Wick

Primary DI
EBESEW824F1
Brand
OTOCELL® Ear Wick
Company
BOSTON MEDICAL PRODUCTS, INC.
Model
EW-824F
Catalog number
EW-824F
Device description
Size: 8 x 24 mm; Type: Fenestrated
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KCNEar Wick

Product Code Classifications

CodeDeviceSpecialtyClass
KCNEar WickEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EBESEW824F1PackageHIBCC50In Commercial Distribution
EBESEW824F0PrimaryHIBCC0

GMDN Terms

TermDefinition
Ear wick, non-biodegradableA non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.

Device Sizes

TypeValueUnit
Length24Millimeter
Outer Diameter8Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags

DUNS number
131855157
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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