Kerlix 2949

GUDID 20884527016638

X-Ray Detectable Round Sponges,X-Large

Cardinal Health, Inc.

Radiopaque woven surgical sponge

• Primary Device ID: 20884527016638
• NIH Device Record Key: 6eb61f66-b6b8-406a-a040-cbf31d0f2cc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kerlix
• Version Model Number: 2949
• Catalog Number: 2949
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch
• Outer Diameter: 1.625 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up
• Special Storage Condition, Specify: Between 0 and 0 *This side up

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884527016631 [Primary]
GS1	20884527016638 [Package]; Contains: 10884527016631; Package: CASE [1000 Units]; In Commercial Distribution
GS1	30884527016635 [Unit of Use]

FDA Product Code

• GDY: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-08-24
• Device Publish Date: 2018-06-23

On-Brand Devices [Kerlix]

• 10884521058484: Bandage Roll,100% Cotton, 6 Ply, Medium
• 40884521020062: AMD Antimicrobial Super Sponges,Medium, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 10884521020030: AMD Antimicrobial Bandage Roll,6 Ply
• 20884527020796: AMD Antimicrobial Gauze Dressing
• 10884521154056: AMD Antimicrobial Bandage Roll,6 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 20884521154046: AMD Antimicrobial Super Sponges,Medium, 0.2% Polyhexamethylene Biguanide HCI (PHMB)
• 20884521020051: AMD Antimicrobial Super Sponges,Medium
• 20884521020044: AMD Antimicrobial Super Sponges,Medium
• 20884521020020: AMD Antimicrobial Bandage Roll,6 Ply
• 20884521081649: Washed Gauze Bolt,3 Ply
• 30884521068319: Super Sponge Saline Dressing
• 10884521058507: Bandage Roll,100% Cotton, 6 Ply, Medium
• 50192253020340: Kerlix Super Sponges
• 20884527023339: Super Sponges,Medium
• 20884527023315: Sponges,12 Ply
• 20884527023308: Super Sponges,X- Large
• 30884527023299: Sponges,12 Ply
• 20884527023285: Sponges,16 Ply
• 20884527023278: Super Sponges,Large
• 20884527023261: Sponges,12 Ply
• 30884527023251: Super Sponges,Medium
• 20884527023247: Super Sponges,Medium
• 20884527023230: Super Sponges,Large
• 20884527023223: Super Sponges,Medium
• 10884527020881: Laparotomy Sponges;X-Ray Detectable Tray Pack
• 10884527020874: Laparotomy Sponges,X-Ray Detectable Tray Pack
• 20884527020864: X-Ray Detectable Laparotomy Sponges,Tray Pack
• 20884527020857: X-Ray Detectable Laparotomy Sponges,Tray Pack
• 20884527020840: X-Ray Detectable Laparotomy Sponges,Tray Pack
• 20884527020833: X-Ray Detectable Laparotomy Sponges,Tray Pack
• 20884527020826: X-Ray Detectable Laparotomy Sponges,Tray Pack
• 20884527020703: Gauze Roll,6 Ply, Large
• 20884527016874: Sponges,16 Ply
• 20884527016836: X-Ray Detectable Round Sponges,X-Large
• 20884527016638: X-Ray Detectable Round Sponges,X-Large
• 20884521083414: Super Sponges
• 20884521068589: X-Ray Detectable Packing Sponge
• 20884521066448: X-Ray Detectable Laparotomy Sponges,Radiopaque, 8 Ply, Stretched, Unfolded
• 20884521066431: X-Ray Detectable Laparotomy Sponges,Radiopaque, 4 Ply, Stretched, Unfolded
• 20884521058528: Medium Gauze Roll,6 Ply
• 20884521058511: Bandage Roll Burn Pack,100% Cotton
• 20884521058498: Bandage Roll,100% Cotton, 6 Ply, Large
• 20884521058474: Bandage Roll,100% Cotton, 6 Ply, Small
• 20884521058467: Bandage Roll,100% Cotton, 8 Ply, Large
• 20884521058450: Bandage Roll,100% Cotton, 6 Ply, Large