Dupaque® DUP94812

GUDID 00809958094723

8 in X 4 in, 12-ply, 20 X 10 mesh gauze X-Ray detectable sponge. Non-Sterile.

Derma Sciences Canada Inc

Radiopaque woven surgical sponge, non-sterile Radiopaque woven surgical sponge, non-sterile Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge Radiopaque woven surgical sponge

• Primary Device ID: 00809958094723
• NIH Device Record Key: 30c15607-3111-4c8d-9aea-73394efac998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dupaque®
• Version Model Number: 94812
• Catalog Number: DUP94812
• Company DUNS: 200564891
• Company Name: Derma Sciences Canada Inc
• Device Count: 10
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00809958094709 [Unit of Use]
GS1	00809958094723 [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