Primspine 824726

GUDID 08434048352784

PRIMSPINE MAMMY Pregnancy Girdle, gray

PRIM S.A.

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