SurgiCount+ 0620-104-360

GUDID 80683534870118

Bulk Vaginal Sponge, 4"X36", 4 ply, STEAM PRETREATMENT, PREWASHED, BLUE LOOP, X-RAY DETECTABLE STRIP, RFID, 200 PCS/CS

A PLUS INTERNATIONAL INC.

Radiopaque woven surgical sponge

• Primary Device ID: 80683534870118
• NIH Device Record Key: 31f75285-b296-44e1-8435-01b667adfbfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiCount+
• Version Model Number: 1
• Catalog Number: 0620-104-360
• Company DUNS: 191705904
• Company Name: A PLUS INTERNATIONAL INC.
• Device Count: 1
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00683534870112 [Primary]
GS1	80683534870118 [Package]; Contains: 00683534870112; Package: Case [200 Units]; In Commercial Distribution

FDA Product Code

• GDY: Gauze/Sponge, Internal, X-Ray Detectable

Sterilization

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

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

[80683534870118]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [SurgiCount+]

• 80683534870125: Bulk Vaginal Sponge, 8"X36", 4 ply, STEAM PRETREATMENT, PREWASHED, BLUE LOOP, X-RAY DETECTABLE S
• 80683534870118: Bulk Vaginal Sponge, 4"X36", 4 ply, STEAM PRETREATMENT, PREWASHED, BLUE LOOP, X-RAY DETECTABLE S
• 80683534870101: Bulk Vaginal Sponge, 4"×18", STEAM PRETREATMENT, X-RAY DETECTABLE, RFID, 200 PCS/CS
• 80683534870095: Bulk Lap Sponge, 8"x108", X-Ray Detectable, RFID, STEAM PRETREATMENT, PREWASHED, 200 Pc(s)/Case