Sheathes3D Pre-Gelled

GUDID 20842418102662

Seamless Viral Barrier End, Polyurethane, 1.18"D Tapered to 4"W x 24"L, Non-sterile, Pre-Gelled Extended Field Ultrasound Probe & Cord Cover, Vaginal/Rectal, Rolled, Individually Wrapped

SHEATHING TECHNOLOGIES, INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile Body-orifice ultrasound imaging transducer cover, basic, non-sterile

• Primary Device ID: 20842418102662
• NIH Device Record Key: b52bbfcb-9045-4777-b857-acd6edbe7088
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheathes3D Pre-Gelled
• Version Model Number: 50001-77244
• Company DUNS: 806806220
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842418102668 [Unit of Use]
GS1	10842418102665 [Primary]
GS1	20842418102662 [Package]; Contains: 10842418102665; Package: CASE [3 Units]; In Commercial Distribution

FDA Product Code

• OIP: Radiology-Diagnostic Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-07-27

On-Brand Devices [Sheathes3D Pre-Gelled]

• 20842418104277: Seamless Viral Barrier, Pre-gelled Latex-Free, 2.2" x 0.8" Face x 8"L, Non-Sterile, Specialty Ul
• 20842418104178: Seamless Viral Barrier, Pre-gelled Latex-Free, 2.25" x 1.1" Face x 8"L, Non-Sterile, Specialty U
• 20842418104147: Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe
• 20842418104048: Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe
• 20842418104031: Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe
• 20842418104024: Seamless Viral Barrier, Polyurethane, 1.18"D x 11"L, Non-Sterile, Pre-Gelled Ultrasound Probe Co
• 20842418104017: Seamless Viral Barrier, Polyurethane, 1.18"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cov
• 20842418102662: Seamless Viral Barrier End, Polyurethane, 1.18"D Tapered to 4"W x 24"L, Non-sterile, Pre-Gelled
• 20842418102594: Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled U
• 20842418102556: Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled U
• 20842418102549: Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled U