Sheathes Pre-Gelled

GUDID 20842418102617

Polyurethane, 7/8"D Tapered to 4"W x 36"L, Non-Sterile, Pre-Gelled Extended Field Ultrasound Probe & Cord Cover, Vaginal/Rectal, Rolled

SHEATHING TECHNOLOGIES, INC.

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

• Primary Device ID: 20842418102617
• NIH Device Record Key: b6874968-0c5a-4a13-bbad-ff551216f785
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheathes Pre-Gelled
• Version Model Number: 50001-27364
• Company DUNS: 806806220
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Device Count: 10
• 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	00842418102613 [Unit of Use]
GS1	10842418102610 [Primary]
GS1	20842418102617 [Package]; Contains: 10842418102610; 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 [Sheathes Pre-Gelled]

• 20842418104192: Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered
• 20842418104260: Pre-Gelled, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L Non-Sterile, Ultrasound Probe Cover, Vag
• 20842418102624: 50001-27964, Case, Polyurethane, 7/8"D Tapered to 4"W x 96"L, Non-Sterile, Pre-Gelled Extended F
• 20842418102617: Polyurethane, 7/8"D Tapered to 4"W x 36"L, Non-Sterile, Pre-Gelled Extended Field Ultrasound Pro
• 20842418102587: Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered
• 20842418102570: Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover with 5" Debris Shield, V
• 20842418102563: Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover with 3" Debris Shield, V
• 20842418102532: Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, V
• 20842418102525: Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, V
• 20842418102518: Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, V
• 20842418102501: Polyurethane, 1"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tape
• 20842418102495: 27380-PT, Each, Polyurethane, 1"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Prove Cover, Vagi
• 20842418102488: Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered
• 20842418102471: Polyurethane, 1"D x 9"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered