FDA.reportPublic FDA data

MENTOR CENTERSCOPE Magnetic Detection Device

Primary DI
00081317004042
Brand
MENTOR CENTERSCOPE Magnetic Detection Device
Company
MENTOR TEXAS L.P.
Model
350-4402
Catalog number
350-4402
Published
2015-09-21
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
LCJEXPANDER, SKIN, INFLATABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011500000
K130813000
K150777000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011500000MENTOR CONTOUR PROFILE TISSUE EXPANDERMentor Corp.2001-12-03LCJ
K130813000MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSMentor Corp.2013-04-11LCJ
K150777000Artoura Breast Tissue ExpanderMentor Worldwide, LLC2015-04-24LCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081317004042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081317004042000813170040420813170040420081317004042

GMDN Terms#

Term, Definition table
TermDefinition
Tissue expander injection port locatorA small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00081317023487Coleman Luer Lock CapCOL-LLCAPCOL-LLCAP2016-09-14
00081317027171MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB130SRSZ-MPB-130S2022-02-15
00081317027188MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB160SRSZ-MPB-160S2022-02-15
00081317027195MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB185SRSZ-MPB-185S2022-02-15
00081317027201MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB210SRSZ-MPB-210S2022-02-15
00081317027218MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB235SRSZ-MPB-235S2022-02-15
00081317027225MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB265SRSZ-MPB-265S2022-02-15
00081317027232MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB290SRSZ-MPB-290S2022-02-15
00081317027249MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB320SRSZ-MPB-320S2022-02-15
00081317027256MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB340SRSZ-MPB-340S2022-02-15
00081317027263MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB390SRSZ-MPB-390S2022-02-15
00081317027270MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB430SRSZ-MPB-430S2022-02-15
00081317027287MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB450SRSZ-MPB-450S2022-02-15
00081317027294MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB480SRSZ-MPB-480S2022-02-15
00081317027300MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB530SRSZ-MPB-530S2022-02-15
00081317027317MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB545SRSZ-MPB-545S2022-02-15
00081317027324MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB590SRSZ-MPB-590S2022-02-15
00081317027331MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB630SRSZ-MPB-630S2022-02-15
00081317027348MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB675SRSZ-MPB-675S2022-02-15
00081317027355MENTOR MemoryGel BOOST Resterilizable Gel SizerRSZMPB730SRSZ-MPB-730S2022-02-15

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Primary DI, Brand, Company table
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