Bard® Renal Sheath 992101

GUDID 10801741095037

Bard® Renal Sheath

C. R. Bard, Inc.

Nephrostomy catheter Nephrostomy catheter

• Primary Device ID: 10801741095037
• NIH Device Record Key: 4ce0de6d-effa-4b78-a324-93404515d6bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard® Renal Sheath
• Version Model Number: 992101
• Catalog Number: 992101
• Company DUNS: 016898496
• Company Name: C. R. Bard, 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: 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)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com

Device Dimensions

• Catheter Gauge: 30 French
• Catheter Gauge: 30 French
• Catheter Gauge: 30 French
• Catheter Gauge: 30 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store near radiation or ultraviolet light sources.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store near radiation or ultraviolet light sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741095030 [Primary]
GS1	10801741095037 [Package]; Contains: 00801741095030; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080944

FDA Product Code

• LJE: CATHETER, NEPHROSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-10

On-Brand Devices [Bard® Renal Sheath]

• 10801741095068: Bard® Renal Sheath
• 10801741095051: Bard® Renal Sheath
• 10801741095044: Bard® Renal Sheath
• 10801741095037: Bard® Renal Sheath
• 10801741095020: Bard® Renal Sheath
• 10801741095013: Bard® Renal Sheath