IMS-2215

GUDID 10889950110468

15x15" Bonded Double Wrap, 480 Pcs.

HU-FRIEDY MFG. CO., LLC

Sterilization packaging, single-use

• Primary Device ID: 10889950110468
• NIH Device Record Key: aea67a17-dc74-48e2-956c-4bb60fc9a761
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IMS-2215
• Catalog Number: IMS-2215
• Company DUNS: 005085972
• Company Name: HU-FRIEDY MFG. CO., LLC
• Device Count: 480
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18004837433
• Email: info@hu-friedy.com
• Phone: 18004837433
• Email: info@hu-friedy.com

Device Dimensions

• Area/Surface Area: 225 Square inch
• Area/Surface Area: 225 Square inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889950110468 [Primary]
GS1	10889950111410 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160755

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-14

Devices Manufactured by HU-FRIEDY MFG. CO., LLC

• 10889950147112 - Hu-Friedy: 2025-09-26 MTO INFINI 20 INST,GRAY,C4,AW SNAP-IN,NH
• 10889950147129 - Hu-Friedy: 2025-09-26 MTO INFINI 20 INST,YLW,C4,AW SNAP-IN,NH
• 10889950147136 - Hu-Friedy: 2025-09-26 MTO INFINI 20 INST,GRN,C4,AW SNAP-IN,NH
• 10889950147143 - Hu-Friedy: 2025-09-26 MTO INFINI 20 INST,RED,C4,AW SNAP-IN,NH
• 10889950147150 - Hu-Friedy: 2025-09-26 MTO INFINI 20 INST,WHT,C4,AW SNAP-IN,NH
• 10889950147167 - Hu-Friedy: 2025-09-26 MTO INFINI 20 INST,BLK,C4,AW SNAP-IN,NH
• 10889950147174 - Hu-Friedy: 2025-09-26 MTO5.5X8,YLW,ALL FM,CUT-OUT PARTSBOX,C2
• 10889950147181 - Hu-Friedy: 2025-09-26 MTO5.5X8,WHT,ALL FM,CUT-OUT PARTSBOX,C2