MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer

Primary DI
00081317002802
Brand
MENTOR Round Moderate Plus Profile Single Use Saline Breast Implant Sizer
Company
MENTOR TEXAS L.P.
Model
351-2475SZ
Catalog number
351-2475SZ
Device description
Round Moderate Plus Profile Saline Breast Implant Sizer, 475cc
Published
2016-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRDSIZER, MAMMARY, BREAST IMPLANT VOLUME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRDMammary SizerUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010709000MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMentor Corp.2001-04-23MRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081317002802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081317002802000813170028020813170028020081317002802

GMDN Terms#

Term, Definition table
TermDefinition
Invasive breast implant sizer, single-useA sterile surgical instrument intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-5731xx@xx.xx

Regulatory Flags#

DUNS number
167450993
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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Primary DI, Brand, Company table
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