Well Leg Holder WLH01

GUDID 10810006684138

Well Leg Holder

PRIMO INC

Freestanding patient positioner, single-use

• Primary Device ID: 10810006684138
• NIH Device Record Key: cf091ed5-68b2-4e67-a7d0-27afb8b40248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well Leg Holder
• Version Model Number: WLH01
• Catalog Number: WLH01
• Company DUNS: 958758146
• Company Name: PRIMO INC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810006684131 [Primary]
GS1	10810006684138 [Package]; Contains: 00810006684131; Package: Each [4 Units]; In Commercial Distribution

FDA Product Code

• ILZ: Accessories, Traction

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: 2021-08-03
• Device Publish Date: 2021-07-26

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• 10810006683742 - Wipe Down Body Wedge Set: 2021-08-03 Wipe Down Body Wedge Set (1 each-BPW04F/ 1 each-BPW04FL) - 12/ST/CA
• 10810006683759 - Wipe Down Body Wedge Set: 2021-08-03 Wipe Down Body Wedge Set (2 each - BPW04F) 12 ST/CA
• 10810006683780 - Glide & Guide Turn System Kit: 2021-08-03 GGTS02 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10F; 12 Kit/Case
• 10810006683797 - Glide & Guide Turn System Kit: 2021-08-03 GGTS02B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW10F; 12 Kit/Case
• 10810006683803 - Glide & Guide Turn System Kit: 2021-08-03 GGTS01 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10R; 10 Kit/Case