Primspine 824726

GUDID 08434048352784

PRIMSPINE MAMMY Pregnancy Girdle, gray

PRIM S.A.

Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis Multiple spinal region orthosis

• Primary Device ID: 08434048352784
• NIH Device Record Key: 28895b0f-1f00-4a51-b4b2-d414e67da849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primspine
• Version Model Number: PRS615G OS
• Catalog Number: 824726
• Company DUNS: 462011560
• Company Name: PRIM S.A.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08434048352784 [Primary]

FDA Product Code

• QSB: Orthosis, Truncal, Pregnancy

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: 2024-03-18
• Device Publish Date: 2024-03-08

Devices Manufactured by PRIM S.A.

• 08431082070186 - Comforsil: 2024-03-18 Silicone insoles with anti-impact discharge
• 08431082070193 - Comforsil: 2024-03-18 Silicone insoles with anti-impact discharge
• 08431082070209 - Comforsil: 2024-03-18 Silicone insoles with anti-impact discharge
• 08431082070216 - Comforsil: 2024-03-18 Silicone insoles with anti-impact discharge
• 08431082070391 - Comforsil: 2024-03-18 Thick toe separator, Silicone
• 08431082070773 - Comforsil: 2024-03-18 Protective tube with internal Gel coating. Mesh fabric 1.5 cm
• 08431082070810 - Comforsil: 2024-03-18 Toe separator, extra fine, silicone
• 08431082070827 - Comforsil: 2024-03-18 Toe separator, extra fine, silicone