PERMALOOP 208938

GUDID 10886705032808

PERMALOOP Suture Blue Braided Tape Loop MO-5 31mm 1/2c Taper 1.3mm 20" (51cm)

Medos International Sàrl

Polyolefin suture, multifilament

• Primary Device ID: 10886705032808
• NIH Device Record Key: a988e381-35d9-4e18-964e-29111155ee0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERMALOOP
• Version Model Number: 208938
• Catalog Number: 208938
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705032808 [Unit of Use]
GS1	20886705032805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220219

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-04
• Device Publish Date: 2022-09-26

On-Brand Devices [PERMALOOP]

• 10886705032808: PERMALOOP Suture Blue Braided Tape Loop MO-5 31mm 1/2c Taper 1.3mm 20" (51cm)
• 10886705032723: PERMALOOP Suture Blue Braided Tape Loop Straight 31mm Taper 1.3mm 20" (51cm)
• 10886705032815: PERMALOOP Suture Blue Braided Tape Loop MO-5 31mm 1/2c Taper 1.3mm 20" (51cm)
• 10886705032730: PERMALOOP Suture Blue Braided Tape Loop Straight 31mm Taper 1.3mm 20" (51cm)