ENLCSLTK1

GUDID 00724995225216

enspire 3000 Leak Test Adapter, ENLCSLTK1

STERIS CORPORATION

Invasive medical device leak tester, mechanical

• Primary Device ID: 00724995225216
• NIH Device Record Key: e25de02e-4ef2-4dec-89f6-2bded9b7f2ff
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: enspire 3000 Leak Test
• Catalog Number: ENLCSLTK1
• Company DUNS: 868205779
• Company Name: STERIS CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995225216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230930

FDA Product Code

• FEB: Accessories, cleaning, for endoscope

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: 2024-06-11
• Device Publish Date: 2024-06-03

Devices Manufactured by STERIS CORPORATION

• 00724995221980 - NA: 2024-08-09 Orthopedic Extension and Abductor Bar Assembly is used with the 7000 Series Surgical Tables.
• 00724995221997 - NA: 2024-08-09 36-inch Imaging Extension without Pad, Velcro is used with the 7000 Series Surgical Tables.
• 00724995222000 - NA: 2024-08-09 36-inch Imaging Extension with 2-inch TLT Pad, Velcro is used with the 7000 Series Surgical Tables.
• 50724995211566 - Prolystica: 2024-08-08 Prolystica HP Enzymatic Manual Cleaner Fragrance Free is formulated to deliver superior performance during manual cleaning proce
• 00724995211585 - Prolystica: 2024-08-08 Prolystica HP Enzymatic Manual Cleaner Dye and Fragrance Free 2.5 Gallon is formulated to deliver superior performance during ma
• 00724995217266 - NA: 2024-08-07 The Replacement Pad Set is used with the PowerLift Plus Stirrups (pair) - Adult 500 pound is used with
• 00724995217273 - NA: 2024-08-07 The Replacement Pad Set is used with PowerLift Freedom Stirrups (pair) - Bariatric 800 pound is used with
• 00724995217242 - Secure-Release: 2024-08-02 The Secure-Release Clamp is designed to safely hold surgical accessories to the side rail and is compatible with STERIS 3000, 40