FDA.report

Up & Up

Primary DI
20794503812348
Company
CIRRUS HEALTHCARE PRODUCTS LLC
Model
81234
Device description
Cirrus Healthcare Products, 245-09-0047, Sleep Earplugs 2 Pair, Nicholas Petry, Npetry@cirrushealthcare.com
Published
2021-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
809994163
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20794503812348PackageGS124In Commercial Distribution
00794503812344PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20794503812348PackageGS124Case00794503812344In Commercial Distribution
00794503812344PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
EWDProtector, Hearing (Insert)UUnknownNEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Earplugs, reusableA device usually used as a pair made of rubber or pliable plastic/silicone material for insertion into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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