PACKS

GUDID 30680651885112

LITHOTOMY PACK I

O&M HALYARD, INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 30680651885112
• NIH Device Record Key: 366656fe-eb1d-43e9-a058-ddc03a8a94cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACKS
• Version Model Number: 88511
• Company DUNS: 081057389
• Company Name: O&M HALYARD, INC.
• 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: 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

Customer Support Contacts

• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10680651885118 [Primary]
GS1	30680651885112 [Package]; Contains: 10680651885118; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083234

FDA Product Code

• KKX: Drape, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-11-06
• Device Publish Date: 2015-12-15

Devices Manufactured by O&M HALYARD, INC.

• 10680651488944 - Halyard: 2024-04-15 Craniotomy Drape with Pouch
• 10680651488951 - Halyard: 2024-04-15 Gyn/Urology Drape with Attached Fluid Collection Pouch
• 10680651488968 - Halyard: 2024-04-15 ORTHOARTS* Hand Drape
• 10680651488975 - Halyard: 2024-04-15 Hip Drape with Clear Leg Pockets
• 10680651488982 - Halyard: 2024-04-15 Pacemaker Drape
• 10680651489330 - Halyard: 2024-04-15 Eye Drape
• 10680651489347 - Halyard: 2024-04-15 Eye Drape
• 10680651489354 - Halyard: 2024-04-15 Eye Drape