PACKS

GUDID 30680651885112

LITHOTOMY PACK I

O&M HALYARD, INC.

General/plastic 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.

• 20885632431163 - Halyard: 2025-01-20 HALYARD* Skin Barrier Arc One Third Circle 1 in Wide
• 20885632431200 - Halyard: 2025-01-20 HALYARD* Skin Barrier Arc One Half Circle 1.25 in Wide
• 20885632431217 - Halyard: 2025-01-20 HALYARD* Skin Barrier Arc One Third Circle 2 in Extra Wide
• 20885632431248 - Halyard: 2025-01-20 HALYARD* Skin Barrier Sheet 4 in x 4 in
• 90680651445912 - Halyard: 2024-12-26 Armboard Cover, 14 in. x 31.5 in. / 35 cm x 80 cm
• 90680651768851 - Halyard: 2024-12-26 T.U.R. Drape 114 in. x 69 in. x 67 in. 289 cm x 175 cm x 170 cm
• 30885632431122 - Halyard: 2024-11-20 HALYARD* Conforming Skin Barrier Ring 2 in OD
• 20885632431132 - Halyard: 2024-11-20 HALYARD* Conforming Skin Barrier Ring 2 in OD