PRIMOBoot, Black/Gray - Small BABBSW

GUDID 00810006683936

PRIMOBoot w/wedge, Black/Gray - Small

PRIMO INC

Heel protector

• Primary Device ID: 00810006683936
• NIH Device Record Key: 6ebad34b-c917-4605-b7cd-0412deaa2520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMOBoot, Black/Gray - Small
• Version Model Number: BABBSW
• Catalog Number: BABBSW
• 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	00810006683912 [Primary]
GS1	00810006683936 [Package]; Contains: 00810006683912; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• FMP: Protector, Skin Pressure

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: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [PRIMOBoot, Black/Gray - Small ]

• 10810006684008: PRIMOBoot, Black/Gray - Small
• 00810006683936: PRIMOBoot w/wedge, Black/Gray - Small