Gems E7009CC

GUDID 10618125152459

Gems Dome Bags Clear Polyethylene Sterile 24in x 15in x .003in 20 per Case

TIDI PRODUCTS, LLC

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• Primary Device ID: 10618125152459
• NIH Device Record Key: e6946341-a67b-4efa-9782-151acd4d91e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gems
• Version Model Number: 30353
• Catalog Number: E7009CC
• Company DUNS: 063519193
• Company Name: TIDI PRODUCTS, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618125152452 [Primary]
GS1	01618125152451 [Previous]
GS1	10618125152459 [Package]; Contains: 00618125152452; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [Gems]

• 00618125177301: Straps Various Zote Foam Reinforced Vinyl .79in x 31.5in x .29in 1 per Each
• 00618125176908: Positioning Aids - Head And Neck
• 00618125175659: Gems Table Pads Gray Ester Foam Nylon 9.2in x 36in x .5in 1 per Each
• 00618125175277: Gems Positioning Aid Kits Ether Foam 1in x 1in x 1in 15 per Set
• 00618125175260: Gems Straps 1in x 1in x 1in 1 per Each
• 00618125171170: Gems Cradle Pads 16in x 15.63in x 1in 1 per Each
• 00618125171095: Gems Cradle Pads 16in x 88.25in x 1in 1 per Each
• 00618125171040: Gems Table Pads Gray 13.68in x 27.24in x 1.2in 1 per Each
• 00618125171019: Gems Positioning Aids - Head And Neck Gray Kit, Various Sizes 8 per Set
• 00618125170982: Gems Patient Positioners Various Various For Spine Surface Coils 3 per Set
• 00618125170944: Gems Positioning Aids - Leg Gray 6.72in x 11.5in x 6.72in 1 per Each
• 00618125170883: Gems Transfer Boards White Polyethylene 23in x 73in x .18in 1 per Each
• 00618125170876: Gems Table Pads 17in x 19in x .5in 1 per Each
• 00618125170869: Gems Table Pads 17in x 66in x .5in 1 per Each
• 00618125170821: Gems Straps White Vinyl 3.25in x 51in 1 per Each
• 00618125170814: Gems Straps Various Various 15.44in x 32in x 6in 1 per Each
• 00618125170807: Gems Straps Various Various 21.44in x 31.44in x 14in 1 per Each
• 00618125170791: Gems Sand Bags Blue Vinyl 8.5in x 14in 1 per Each
• 00618125170784: Gems Positioning Aids - Leg Kit, Various Sizes 3 per Set
• 00618125170760: Gems Positioning Aids - Blocks 10.25in x 11in x 4.5in 1 per Each
• 00618125170722: Gems Positioning Aids - Leg 6in x 6in 1 per Each
• 00618125170685: Gems Straps Various Various Universal Fit 10 per Set
• 00618125170661: Gems Straps Various Various 6in x 46in 1 per Each
• 00618125170654: Gems Table Pads Gray 15.5in x 60in x 2in 1 per Each
• 00618125170647: Gems Positioning Aids - Wedges Kit, Various Sizes 12 per Set
• 00618125170593: Gems Positioning Aids - Blocks 3in x 5in x .88in 6 per Set
• 00618125170586: Gems Positioning Aids - Rectangles Gray 5.25in x 14.5in x .5in 1 per Each
• 00618125170579: Gems Positioning Aids - Rectangles Gray 14in x 14in x 1.3in 1 per Each
• 00618125170562: Gems Positioning Aids - Rectangles Gray 5.25in x 14.5in x 1in 1 per Each
• 00618125170555: Gems Positioning Aids - Rectangles Gray 3in x 14.5in x 1in 1 per Each
• 00618125170548: Gems Positioning Aids - Rectangles Gray 3in x 5in x .88in 1 per Each
• 00618125170531: Gems Positioning Aids - Rectangles Gray 14in x 24in x 2.5in 1 per Each
• 00618125170524: Gems Positioning Aids - Head And Neck Gray 3in x 7.25in x 2.5in 1 per Each
• 00618125170517: Gems Positioning Aids - Leg 12.5in x 16in x 7.5in 1 per Each
• 00618125170500: Gems Positioning Aids - Wedges Gray 1.75in x 4in x 14.5in 1 per Each
• 00618125170494: Gems Positioning Aids - Wedges Gray 3.78in x 8in x 10in 1 per Each
• 00618125170487: Gems Positioning Aids - Wedges Gray 10in x 10in x 14in 1 per Each
• 00618125170470: Gems Positioning Aids - Wedges Gray 3in x 10in x 10in 1 per Each
• 00618125170425: Gems Positioning Aids - Wedges 9in x 9in x 9in 2 per Set
• 00618125170418: Gems Positioning Aids - Wedges 9in x 9in x 3in 2 per Set
• 00618125170401: Gems Straps Various Various 14in x 46in 1 per Each
• 00618125170371: Gems Straps Various Various Fits CT Hilight, Hispeed Advantage, CT 8800 AND CT 3 per Set
• 00618125167869: Gems Straps Gray 2in x 85in x 1in 1 per Each
• 00618125167661: Gems Straps White 1.5in x 30in x 1in 1 per Each
• 00618125167623: Gems Positioning Aids - Leg Ester Foam 15.5in x 30.5in x 10.65in 1 per Each
• 00618125167531: Gems Positioning Aid Kits Ester Foam 1in x 1in x 1in 13 per Set
• 00618125167487: Gems Positioning Aids - Leg Ether Foam 1in x 1in x 1in 2 per Set
• 00618125166961: TIDI Positioning Aids - Head And Neck White 1.73in x 24.8in x 1in 1 per Each
• 00618125165445: Positioning Aids - Head And Neck
• 00618125164462: 31121