Hygienic Sheath 5942503

GUDID 60192155942501

HYGIENIC SHEATHS #0 - 200 PCS

CARESTREAM DENTAL LLC

Medical equipment drape, single-use, non-sterile

• Primary Device ID: 60192155942501
• NIH Device Record Key: 449208a2-fe01-4eac-a559-8b098c7e154d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hygienic Sheath
• Version Model Number: Hygienic Sheath
• Catalog Number: 5942503
• Company DUNS: 019796106
• Company Name: CARESTREAM DENTAL LLC
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00192155942509 [Unit of Use]
GS1	40192155942507 [Primary]
GS1	60192155942501 [Package]; Contains: 40192155942507; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• KQM: Camera, Surgical And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

On-Brand Devices [Hygienic Sheath]

• 60192155942570: HYGIENIC SHEATHS #2 - 200 PCS
• 60192155942525: HYGIENIC SHEATHS #1 - 200 PCS
• 60192155942501: HYGIENIC SHEATHS #0 - 200 PCS