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PANPAC MEDICAL CORPORATION · Model BA100 · UDI-DI 04715309125250

HHM Prescription

510(k) clearances

Adverse events

Recalls

132

Facilities

Description

The Uterine Sound is used to gauge the depth and position of the uterine cavity. It is also helpful with the placement of IUDs and the verification of the intrauterine position and length for HSG procedures. The proximal portion of the sound is 3.5 mm in diameter tapering to 2.5 mm at the distal portion with a bulbous tip to reduce the risk of perforation. Malleable to adapt to anatomical variations.It is a sterile, disposable, single-use only device.

Recalls

Date	Firm	Reason
2024-07-31	CooperSurgical, Inc.	During the manufacturing process the devices were laser-marked with the incorrect part number.
2024-07-31	CooperSurgical, Inc.	During the manufacturing process the devices were laser-marked with the incorrect part number.
2019-12-11	Centurion Medical Products Corporation	Incomplete seals on the sterile package may compromise the sterility
2016-10-28	Hologic, Inc	Breach in sterile barrier compromising product sterility

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.