FDA.report

Integra® Miltex®

Primary DI
H834MH193160
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
MH19-316
Catalog number
MH19-316
Device description
Billeau Ear Loop 6-1/2", Medium, Size 2: 3.5mm wide, Flexible
Published
2018-01-24
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
JYQLOOP, WIRE

Product Code Classifications

CodeDeviceSpecialtyClass
JYQLoop, WireEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780439929PrimaryGS10
H834MH193160SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178043992910381780439929

GMDN Terms

TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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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