When a customer refers to a “gauge,” they are referring to the Brown and Sharpe (BS) gauge of steel.

The following BS gauge correlates to USP size.

BS 18 = USP 7

BS 19 = USP 6

BS 20 = USP 5

BS 22 = USP 4

BS 23 = USP 3

BS 24 = USP 2

BS 25 = USP 1

BS 26 = USP 0

BS 28 = USP 2-0

BS 30 = USP 3-0

BS 32 and 34 = USP 4-0

BS 35 = USP 5-0

Non-clinical testing demonstrated that a representative steel suture is MR Conditional. A patient with this suture can be scanned safely immediately after

placement of the suture under the following conditions:

• Static magnetic field of 1.5T and 3.0T
• Maximum spatial gradient magnetic field of 2360-Gauss/cm
• Normal operating mode of operation for the MRI system (whole body averaged SAR, 2-W/kg) for 15 minutes of scanning, per pulse sequence

Under the scan conditions defined above, the steel suture is expected to produce a maximum temperature rise of less than 9.4 C after 15 minutes of

continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 24 mm from the titanium clip when imaged with a gradient echo

pulse sequence and a 3.0T MRI system.