IMS-2212

GUDID 10889950110451

12x12" Bonded Double Wrap, 480 Pcs.

HU-FRIEDY MFG. CO., LLC

Sterilization packaging, single-use

• Primary Device ID: 10889950110451
• NIH Device Record Key: 363ad40b-95ee-4481-a52e-dc7d72569fed
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IMS-2212
• Catalog Number: IMS-2212
• 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: 144 Square inch
• Area/Surface Area: 144 Square inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889950110451 [Primary]
GS1	10889950111397 [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

• 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
• 10889950146351 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,GREEN,4 INST,C12
• 10889950146276 - Hu-Friedy: 2025-04-25 MTOINFINITY HGD 12INST CASS,PRP,C4,AW,NH
• 10889950146269 - Hu-Friedy: 2025-04-21 MTOCUSTOM 11X16,CASS,RED,C6,2COM,5RG,18L
• 10889950146221 - Hu-Friedy: 2025-04-10 Hinged Statim, 12-inst, Red, NH, AW