FDA.report

PremierPro

Primary DI
10818566017724
Brand
PremierPro
Company
SVS LLC
Model
3611
Catalog number
3611
Device description
Ear & Ulcer Syringe, 3oz, DEHP Free, Sterile
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JYHExcavator, Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYHExcavator, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818566017724PackageGS150In Commercial Distribution
00818566017727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601772410818566017724
00818566017727008185660177278185660177270818566017727

GMDN Terms

TermDefinition
Ear syringeA device used to flush the ear canal with an irrigating solution. It is typically available in two main design mechanisms that are used to carefully exert pressure on the irrigating fluid: 1) a cylindrical barrel with a plunger that have finger and thumb rings respectively mounted onto them for the operator to apply the necessary pressure; and 2) an elastomeric rubber, one-piece bulb that tapers to a thin nozzle that fits into the outer ear canal. This device may be used by a healthcare professional or by the patient/end user. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-855-531-7699info@s2s-global.com

Regulatory Flags

DUNS number
831375089
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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