DEVICE: MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer (00081317002994)

Device Identifier (DI) Information

MENTOR CONTOUR PROFILE Single Use Saline Breast Implant Sizer
351-0712SZ
In Commercial Distribution
351-0712SZ
MENTOR TEXAS L.P.
00081317002994
GS1

1
167450993 *Terms of Use
CONTOUR PROFILE Saline Breast Implant Sizer, 350cc
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Invasive breast implant sizer, single-use A 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 is typically a balloon-like elastomer pouch with tubing that is placed in the pocket, filled to an optimal volume, and then removed. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MRD SIZER, MAMMARY, BREAST IMPLANT VOLUME
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K010709 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

73de8321-ce05-4b08-baff-63b867c357ce
July 06, 2018
3
May 16, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)235-5731
xx@xx.xx
CLOSE