Pro-Fit Knee Brace-Large Size

GUDID 00859718007234

Emsi

Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis

• Primary Device ID: 00859718007234
• NIH Device Record Key: e9b9e55f-39ca-4384-98a2-2b8d4c5e0009
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Fit Knee Brace-Large Size
• Version Model Number: FLEBKX0001 – Large Pro- Fit
• Company DUNS: 932471881
• Company Name: Emsi
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859718007234 [Primary]

FDA Product Code

• ITQ: Joint, Knee, External Brace

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-29
• Device Publish Date: 2023-03-21

Devices Manufactured by Emsi

• 00858688006964 - Electrode 45 x 45 16 PK: 2023-09-28
• 00858688006971 - Electrode 1.75 x 1.75 4 pack: 2023-09-28
• 00859718007074 - Electrode 1.75 x 1.75 - 24 PK: 2023-09-28
• 00859718007081 - Electrode 4.0 x 7.0- Dispersive: 2023-09-28
• 00859718007098 - Electrode 1 Inch Round 4 PK: 2023-09-28
• 00859718007104 - Electrode 2" round 4pk: 2023-09-28
• 00859718007111 - Electrode 3 Inch Round 4PK: 2023-09-28
• 00859718007135 - Electrode 2 x 4 Inch Rectangle: 2023-09-28