Dupaque® DUP94815

GUDID 00809958091913

8 in X 4 in H-Fold, 12-ply, 20 X 10 mesh gauze X-Ray detectable sponge. Banded in 5s. Non-Sterile.

Derma Sciences Canada Inc

Radiopaque woven surgical sponge, non-sterile

• Primary Device ID: 00809958091913
• NIH Device Record Key: 2db7689b-186f-4adb-afa9-ea0b6a7f5a3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dupaque®
• Version Model Number: 94815
• Catalog Number: DUP94815
• Company DUNS: 200564891
• Company Name: Derma Sciences Canada Inc
• Device Count: 30
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00809958091906 [Unit of Use]
GS1	00809958091913 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-23
• Device Publish Date: 2018-10-23

On-Brand Devices [Dupaque®]

• 00809958095812: 4 in X 4 in, 12-ply, 20 X 10 mesh gauze sponge banded in 10s, which contains an X-ray detectable
• 00809958095317: 4 in X 4 in H-Fold, 32-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 5s. Sterilized
• 00809958095225: 3 in X 3 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded. Sterilized.
• 00809958094822: 8 in X 4 in, 12-ply, 20 X 10 mesh gauze X-Ray detectable sponge. Banded in 10s. Non-Sterile.
• 00809958094723: 8 in X 4 in, 12-ply, 20 X 10 mesh gauze X-Ray detectable sponge. Non-Sterile.
• 00809958094617: 4 in X 4 in, 16-ply, 20 X 10 mesh gauze sponge, which contains an X-ray detectable monofilament.
• 00809958094518: 4 in X 4 in, 12-ply, 20 X 10 mesh gauze sponge, which contains an X-ray detectable monofilament.
• 00809958094419: 4 in X 4 in, 8-ply, 20 X 10 mesh gauze sponge, which contains an X-ray detectable monofilament.
• 00809958094129: 8 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 5s. Sterilized
• 00809958093825: 8 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 10s. Hard tra
• 00809958093726: 4 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 5s. Sterilized
• 00809958093023: 4 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 10s. Sterilize
• 00809958092521: 4 in X 4 in H-Fold, 16-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 10s. Sterilize
• 00809958092323: 4 in X 8 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 10s. Sterilize
• 00809958091913: 8 in X 4 in H-Fold, 12-ply, 20 X 10 mesh gauze X-Ray detectable sponge. Banded in 5s. Non-Steril
• 00809958085721: 4 in X 4 in H-Fold, 16-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 5s. Sterilized
• 00809958009628: 4 in X 8 in, 16-ply, 26 X 18 mesh X-Ray detectable (Opake) sponge. Banded in 10s. Sterile.
• 00809958009529: 4 in X 4 in H-fold, 16-ply, 26 X 18 mesh X-Ray detectable (Opake) sponge. Banded in 10s. Sterile