FDA.report

Integra® Miltex®

Primary DI
H834193840
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-384
Catalog number
19-384
Device description
Metal Ear Syringe, (4 oz) Capacity, with Bulbous Tip and Tapered Tip
Published
2017-12-21
Public version status
Update
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
KYZSYRINGE, IRRIGATING (NON DENTAL)

Product Code Classifications

CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780419860PrimaryGS10
H834193840SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178041986010381780419860

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
081277700
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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