GE Healthcare

GUDID 00618125187195

OEC ® Disposables, 9 inch Image Intensifier 9800, 9900 & Elite™ 21cm CFM, 10 per Case

TIDI PRODUCTS, LLC

Medical equipment drape, single-use

• Primary Device ID: 00618125187195
• NIH Device Record Key: c1a92358-cc8e-4286-8a19-f1ca6c24127c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE Healthcare
• Version Model Number: 33307
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618125187195 [Primary]
GS1	01618125187194 [Previous]
GS1	10618125187192 [Package]; Package: Case [10 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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [GE Healthcare]

• 00618125183579: Elegance Mattress Pad, 1 Each
• 00618125183562: MRI Positioning Kit
• 00618125178490: REST, LEG, 10" X 24" X 18"
• 00618125175925: Pad, Table, OEC UroView 2800, 1 per Each
• 00618125170739: Ge Healthcare Patient Positioners 15.5in x 15.3in x 2in 2 per Set
• 00618125162505: CUSHION, LARGE INFANT HEAD, 1 per Each
• 00618125162499: CUSHION, MEDIUM INFANT HEAD, 1 per Each
• 00618125162482: CUSHION, SMALL INFANT HEAD, 1 per Each
• 00618125146154: Positioning Aids - Wedges 7.3in x 1in x 3in 1 per Each
• 00618125146147: WEDGE, AXIAL HEADHOLDER, 10°
• 00618125145775: Axial Head Holder, Foam
• 00618125187195: OEC ® Disposables, 9 inch Image Intensifier 9800, 9900 & Elite™ 21cm CFM, 10 per Case
• 00618125187171: 12"II 9900,9800 ELITE,31CM
• 00618125187164: OEC ® Disposables, 9 inch Image Intensifier 9800, 9900 & Elite™ 21cm CFM, 20 per Case
• 00618125155279: Sterile Mobile XR Tube Drape, 20 per Case
• 10618125187185: OEC Disposables, 12 inch Image Intensifer 9800, 9900, and Elite 31cm, 10 per Case
• 10618125183859: 4K Monitor Drape, Clear Polyethylene Sterile 20 per Case
• 00618125187157: Purple C-Bow Drape for 9900, 9800 Elite and CFM Elite, 20 per Case
• 01618125187194: OEC ® Disposables, 9 inch Image Intensifier 9800, 9900 & Elite™ 21cm CFM, 10 per Case
• 01618125187187: OEC Disposables, 12 inch Image Intensifer 9800, 9900, and Elite 31cm, 10 per Case
• 01618125187170: 12"II 9900,9800 ELITE,31CM
• 01618125187163: OEC ® Disposables, 9 inch Image Intensifier 9800, 9900 & Elite™ 21cm CFM, 20 per Case
• 01618125183851: 4K Monitor Drape, Clear Polyethylene Sterile 20 per Case
• 01618125155278: Sterile Mobile XR Tube Drape, 20 per Case