ThermoTek WRAP, BACK, SPU, UF, QTY 10 CTN 0P9BBACKMR3-U-CTN

GUDID 00850033615418

WRAP, BACK, SPU, UF, QTY 10 CTN

THERMOTEK, INC.

Circulating-fluid localized thermal therapy system pack, single-use

• Primary Device ID: 00850033615418
• NIH Device Record Key: d2384082-42be-465f-96f7-d59c0f3d8c45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoTek WRAP, BACK, SPU, UF, QTY 10 CTN
• Version Model Number: 0P9BBACKMR3-U-CTN
• Catalog Number: 0P9BBACKMR3-U-CTN
• Company DUNS: 847899911
• Company Name: THERMOTEK, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033615418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061866

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

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: 2026-02-26
• Device Publish Date: 2026-02-18

Devices Manufactured by THERMOTEK, INC.

• 00850033615081 - ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZE: 2026-03-02 WRAP, BACK W/BRACE,LSO,ONE-SIZE
• 00850033615104 - ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13": 2026-03-02 WRAP, KNEE,ROM BRACE, 2XL, 13"
• 00850033615135 - ThermoTek WRAP, KNEE, ROM BRACE, 3XL, 13": 2026-03-02 WRAP, KNEE, ROM BRACE, 3XL, 13"
• 00850033615142 - ThermoTek WRAP, KNEE, ROM BRACE, L, 13": 2026-03-02 WRAP, KNEE, ROM BRACE, L, 13"
• 00850033615159 - ThermoTek WRAP, FOOT/ANKLE, SPU , UF: 2026-03-02 WRAP, FOOT/ANKLE, SPU , UF
• 00850033615166 - ThermoTek WRAP, HIP, MED, W/HARNESS, SPU, UF: 2026-03-02 WRAP, HIP, MED, W/HARNESS, SPU, UF
• 00850033615173 - ThermoTek WRAP, HIP, STND, SPU, UNFILLED: 2026-03-02 WRAP, HIP, STND, SPU, UNFILLED
• 00850033615180 - ThermoTek WRAP, KNEE, ROM BRACE, M, 13": 2026-03-02 WRAP, KNEE, ROM BRACE, M, 13"