POLYGLYTONE 6211 833-135

GUDID 14026704603906

Polyglytone 6211 Size 2-0 36" CST-43 Needle T Needle BSC

TELEFLEX INCORPORATED

Polyglytone suture

• Primary Device ID: 14026704603906
• NIH Device Record Key: 814c3b48-2fd3-47fd-a104-3db49f72c465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYGLYTONE 6211
• Version Model Number: IPN000862
• Catalog Number: 833-135
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	14026704603906 [Package]; Contains: 34026704603900; Package: Box [12 Units]; In Commercial Distribution
GS1	34026704603900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042141

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

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: 2019-02-15
• Device Publish Date: 2019-01-15

On-Brand Devices [POLYGLYTONE 6211]

• 14026704603906: Polyglytone 6211 Size 2-0 36" CST-43 Needle T Needle BSC
• 24026704603903: Polyglytone 6211 Size 2-0 36" CST-43 Needle T Needle BSC