SHARD Premium+ IV Catheters

GUDID 10814639026259

SHARD Premium+ IV Catheters. 20Gx 1.25" with Flashback chamber. Radiopague. Pink. Sterile. Single Use.

APPLIED DENTAL, INC.

Suction/irrigation tubing, single-use

• Primary Device ID: 10814639026259
• NIH Device Record Key: c355a919-0e26-4ed3-9533-f9833c5c41a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHARD Premium+ IV Catheters
• Version Model Number: CAT-2032
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place. Avoid direct sun light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639026252 [Primary]
GS1	10814639026259 [Package]; Contains: 00814639026252; Package: Box [50 Units]; In Commercial Distribution
GS1	20814639026256 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083429

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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: 2023-09-15
• Device Publish Date: 2023-09-07

On-Brand Devices [SHARD Premium+ IV Catheters]

• 10814639026273: SHARD Premium+ IV Catheters. 24Gx 0.75" with Flashback chamber. Radiopague. Yellow. Sterile. Si
• 10814639026266: SHARD Premium+ IV Catheters. 22Gx 1" with Flashback chamber. Radiopague. Blue. Sterile. Single
• 10814639026259: SHARD Premium+ IV Catheters. 20Gx 1.25" with Flashback chamber. Radiopague. Pink. Sterile. Sing
• 10814639026242: SHARD Premium+ IV Catheters. 20Gx 1" with Flashback chamber. Radiopague. Pink. Sterile. Single
• 10814639026235: SHARD Premium+ IV Catheters. 18Gx 1.25" with Flashback chamber. Radiopague. Green. Sterile. Sin