Devon 52000058

GUDID 10884527007028

Circumcision Tray,Straps

Cardinal Health, Inc.

Circumcision kit, single-use

• Primary Device ID: 10884527007028
• NIH Device Record Key: 03bf5eb6-ffd0-4c15-8a42-c0cf8d47e969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Devon
• Version Model Number: 52000058
• Catalog Number: 52000058
• Company DUNS: 080935429
• Company Name: Cardinal Health, 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: true
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 1.1 Centimeter
• Outer Diameter: 1.1 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884527007028 [Package]; Contains: 20884527007025; Package: CASE [20 Units]; In Commercial Distribution
GS1	20884527007025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040052

FDA Product Code

• HFX: CLAMP, CIRCUMCISION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-15
• Device Publish Date: 2016-09-24

On-Brand Devices [Devon]

• 10884527020171: Suture Removal Kit,7044 Suture Removal Kit
• 20884527020154: Suture Removal Kit,7042 Suture Removal Kit
• 10884527020140: Suture Removal Kit,7046 Suture Removal Kit
• 20884527020062: Suture Removal Kit,7044-MHH Suture Removal Kit
• 20884527016546: 1822 Foam Block Needle Counter
• 20884527016539: 1820 Foam Block Needle Counter
• 10884527016525: 1812 Foam Block Needle Counter
• 20884527016508: 1880 Foam Block Needle Counter
• 20884527016492: 1630 Foam Strip Needle Counter
• 10884527016471: 1810 Foam Block Needle Counter
• 10884527016464: 1100 Single Magnet Needle Counter,Black
• 20884527016454: 1842 Foam Block Needle Counter
• 20884527016447: 1910 Foam Block Needle Counter
• 20884527016423: 1920 Foam Block Needle Counter
• 10884527016419: 1930 Foam Block Needle Counter
• 10884527016402: 1922 Foam Block Needle Counter
• 20884527016393: 1960 Foam Block Needle Counter
• 20884527016317: 1840 Foam Block Needle Counter
• 20884527016287: 1330 Double Foam Strip Needle Counter
• 10884527016273: 1614 Foam Strip Needle Counter
• 20884527016249: 1540 Double Magnet Needle Counter,White
• 10884527016235: 1105 Foam Strip Needle Counter
• 20884527016225: 1360 Foam Strip Needle Counter
• 10884527016211: 1200 Double Magnet Needle Counter,Black
• 10884527016204: 1315 Foam Strip Needle Counter
• 10884527016198: 1314 Foam Strip Needle Counter
• 10884527016181: 1260 Double Magnet Needle Counter,Black
• 20884527016171: 1230 Double Magnet Needle Counter,Black
• 10884527016167: 1110 Single Magnet Needle Counter,Black
• 20884527016157: 1530 Double Magnet Needle Counter,Black
• 20884527016041: Skin Marker,Fine Tip
• 10884527015962: Printed Medication Labels
• 20884527015952: Utility Marker with Preprinted Labels
• 10884527015917: Utility Marker Labels
• 10884527015900: Anti-fog Solution,1910 Needle Counter
• 10884527015894: Scope Adjustment Bag
• 20884527015884: Anti-Fog Solution with Foam Pad
• 20884527015839: Tube Holder,Fixed Touch Fasten Strap
• 10884527015825: Tube Holder,Removable Touch Fasten Strap
• 20884527015815: Blade Shield Scalpel Holder
• 10884527015801: Instrument Pouch,Double Pocket
• 20884527015792: Micro Tip Wipe
• 20884527011763: Light Handle
• 10884527011742: Scope Adjustment Bag
• 10884527011735: Light Glove
• 20884527011718: Light Glove
• 20884527011701: Light Glove
• 20884527011695: Light Handle
• 10884527011681: Light Handle
• 10884527011629: 7075 Staple Remover