SheathesISO

GUDID 20842418102273

Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long, Individually Wrapped

SHEATHING TECHNOLOGIES, INC.

Body-orifice ultrasound imaging transducer cover, basic

• Primary Device ID: 20842418102273
• NIH Device Record Key: 39f1ac86-c288-4c7c-b411-72dfbab9e9e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SheathesISO
• Version Model Number: 70336
• Company DUNS: 806806220
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Device Count: 75
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842418102279 [Unit of Use]
GS1	10842418102276 [Primary]
GS1	20842418102273 [Package]; Contains: 10842418102276; Package: CASE [6 Units]; In Commercial Distribution

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-08-15
• Device Publish Date: 2018-02-28

On-Brand Devices [SheathesISO]

• 20842418103294: Isoprene, 1.18"D x 11.81"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, V
• 20842418100804: Isoprene, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seaml
• 20842418102273: Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, S
• 10842418100791: Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straig
• 20842418100781: Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straig
• 20842418100774: Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straig