Premium PGLA Sutures

GUDID 10814639023876

Premium PGLA Suture, Size 1, 40mm 1/2 Cir Taper Point, Violet, 27"

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament

• Primary Device ID: 10814639023876
• NIH Device Record Key: 34980440-36b1-442d-9557-e1bedb2272cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium PGLA Sutures
• Version Model Number: PXXL-1G27T40
• Company DUNS: 017524666
• Company Name: APPLIED DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639023879 [Primary]
GS1	10814639023876 [Package]; Contains: 00814639023879; Package: box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161629

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-15
• Device Publish Date: 2018-08-13

Devices Manufactured by APPLIED DENTAL, INC.

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• 10814639026488 - Premium UNIFY Fast Plain Gut Sutures: 2024-05-29 Premium UNIFY Fast Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Conventional Cut, 18"
• 10814639026228 - AD Surgical: 2023-09-15 Disposable Aesthetic Skin Marker. Single Tip 1mm in White Color with ruler and 6 blank labels. Sterile. 1 pc
• 10814639026235 - SHARD Premium+ IV Catheters: 2023-09-15 SHARD Premium+ IV Catheters. 18Gx 1.25" with Flashback chamber. Radiopague. Green. Sterile. Single Use.
• 10814639026242 - SHARD Premium+ IV Catheters: 2023-09-15 SHARD Premium+ IV Catheters. 20Gx 1" with Flashback chamber. Radiopague. Pink. Sterile. Single Use.
• 10814639026259 - SHARD Premium+ IV Catheters: 2023-09-15 SHARD Premium+ IV Catheters. 20Gx 1.25" with Flashback chamber. Radiopague. Pink. Sterile. Single Use.
• 10814639026266 - SHARD Premium+ IV Catheters: 2023-09-15 SHARD Premium+ IV Catheters. 22Gx 1" with Flashback chamber. Radiopague. Blue. Sterile. Single Use.
• 10814639026273 - SHARD Premium+ IV Catheters: 2023-09-15 SHARD Premium+ IV Catheters. 24Gx 0.75" with Flashback chamber. Radiopague. Yellow. Sterile. Single Use.