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Sheathes3D
SHEATHING TECHNOLOGIES, INC. · Model 65-IL486-22110-3 · UDI-DI 10842418104331
0
510(k) clearances
1
Adverse events
2
Recalls
34
Facilities
Description
Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face to 15.2cm x 122cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5 & 2.0cm) & Adapter, Tilt-Out Style
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-07-07 | Hologic, Inc. | The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-h |
| 2016-05-19 | Devicor Medical Products Inc | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. |
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Get your free API keyRead the docsData 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.