IMS-2224

GUDID 10889950110482

24x24" Bonded Double Wrap, 240 Pcs.

HU-FRIEDY MFG. CO., LLC

Sterilization packaging, single-use

• Primary Device ID: 10889950110482
• NIH Device Record Key: 65db7dd7-dd02-486f-bb0a-16326485d266
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IMS-2224
• Catalog Number: IMS-2224
• Company DUNS: 005085972
• Company Name: HU-FRIEDY MFG. CO., LLC
• Device Count: 240
• 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: 576 Square inch
• Area/Surface Area: 576 Square inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889950110482 [Primary]
GS1	10889950111427 [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

• 10889950146252 - Hu-Friedy: 2025-06-10 Nebraska 128/Nevi 1 Discoid EE2 Scaler
• 10889950087692 - HU-FRIEDY: 2025-05-21 RCPGL1/RCP10-1/2 DE Plugger, #6 Handle
• 10889950146375 - Hu-Friedy: 2025-05-13 MTO5.5X8,BLUE,ALL FM,CUT-OUT PARTSBOX,C2
• 10889950146382 - Hu-Friedy: 2025-05-13 MTO5.5X8,GRN,ALL FM,CUT-OUT PARTSBOX,C2
• 10889950146313 - Hu-Friedy: 2025-05-02 MTO 8X11 SIG 20INST,YLW,3 ROWS LP,2COMP
• 10889950146320 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,GRAY,4 INST,C12
• 10889950146337 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,PURPLE,4 INST,C12
• 10889950146344 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,BLUE,4 INST,C12