Atlanta Healthcare Services OcuDrape® S315NS

GUDID 10852171007749

PVA Instrument Wipe with Eye Drain Wick 2IN1, Round Corners 2mm, Non-sterile

ATLANTA HEALTHCARE SERVICES, INC.

Ophthalmic sponge

• Primary Device ID: 10852171007749
• NIH Device Record Key: 5dd8ec34-7069-4389-82fb-1d10f65f4d63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atlanta Healthcare Services OcuDrape®
• Version Model Number: 10852171007749
• Catalog Number: S315NS
• Company DUNS: 130599421
• Company Name: ATLANTA HEALTHCARE SERVICES, INC.
• Device Count: 400
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com
• Phone: +1(404)812-9886
• Email: service@ocudrape.com

Device Dimensions

• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch
• Width: 3.15 Inch
• Length: 3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852171007742 [Unit of Use]
GS1	10852171007749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942642

FDA Product Code

• HOZ: Sponge, ophthalmic

Sterilization

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

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

[10852171007749]

Ethylene Oxide;Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-31
• Device Publish Date: 2016-09-29

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• 10852171007954: Instrument/equipment cover drape, Clear Plastic 22 x 18 in w/ 22" Tape Strip., single use, Steri
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• 10852171007824: PVA Eye Drain Wick 8 Inch, Non-sterile
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• 10852171007770: PVA Instrument Wipe Kit, 2IN1 Wipe & Eye Drain Wick, Corneal Light Shield, STERILE
• 10852171007763: PVA Instrument Wipe Kit, 2IN1 Wipe & Eye Drain Wick,Corneal Light Shield Non-sterile
• 10852171007756: PVA Instrument Wipe with Eye Drain Wick 2IN1, Round Corners 2mm, STERILE
• 10852171007749: PVA Instrument Wipe with Eye Drain Wick 2IN1, Round Corners 2mm, Non-sterile
• 10852171007732: PVA Instrument Wipe, Square 76 mm x 76 mm x 2mm STERILE
• 10852171007725: PVA Instrument Wipe, Square 76 mm x 76 mm x 2mm, Non-sterile
• 10852171007718: PVA Instrument Wipe, Round Corners 80 mm x 76 mm x 2mm STERILE
• 10852171007701: PVA Instrument Wipe, Round Corners 80 mm x 76 mm x 2mm Non-sterile
• 10852171007633: Suture Bag-Utility Cover, Clear Plastic 8x15" with Tape Strip & Gusset
• 10852171007558: Ophthalmic Drape, Oval Aperture with Fluid Pouch
• 10852171007541: Ophthalmic Drape, Oval Aperture with Fluid Pouch
• 10852171007534: Ophthalmic Drape, Full Incise with Fluid Pouch
• 10852171007527: Ophthalmic Drape, Full Incise with Fluid Pouch
• 10852171007503: Ophthalmic Drape, Oval Aperture 2.5 In. wide x 1.5 In., Embossed Plastic 16 In. x 16 In.
• 10852171007497: Ophthalmic Drape, Oval Aperture 2.5 In. wide x 1.5 In., Embossed Plastic 16 In. x 16 In.
• 10852171007480: Ophthalmic Drape, Full Incise, Embossed Plastic 16 In. x 16 In.
• 10852171007473: Ophthalmic Drape, Full Incise, Embossed Plastic 16 In. x 16 In.
• 10852171007466: Ophthalmic Drape, Round Aperture, Embossed Plastic 16 In. x 16 In.
• 10852171007459: Ophthalmic Drape, Round Aperture, Embossed Plastic 16 In. x 16 In.
• 10852171007435: Ophthalmic Bilateral Fenestrated Drape with Adhesive Tape , Blue SMS non-woven
• 10852171007428: Ophthalmic Drape, Full Incise, No Pouch 48 x 51 Embossed Plastic
• 10852171007411: Ophthalmic Drape, Aperture, Embossed Plastic, 48" X 51"
• 10852171007404: Ophthalmic Drape Incise with Single Fluid Pouch, Embossed Plastic 48 x 51 In.
• 10852171007398: Ophthalmic Drape, Aperture, Single Fluid Pouch w/PVA Eye Drain Embossed Plastic 40x48"
• 10852171007381: Ophthalmic Drape Incise with single fluid pouch
• 10852171007374: Ophthalmic Drape, Round Incise 3 In., No pouches, Blue Non-woven
• 10852171007367: Ophthalmic Drape, Incise, No pouches, Blue Non-woven
• 10852171007350: Ophthalmic Drape, Oval Aperture 3" with Adhesive, No Pouch, Blue Non-woven
• 10852171007329: Ophthalmic Drape, Incise, Breather Bar, NO POUCH, Blue SMS Non-woven
• 10852171007312: Ophthalmic Drape, Aperture, Breather Bar, NO POUCH, Blue SMS Non-woven
• 10852171007305: Ophthalmic Drape, Aperture, Clear Poly Drape with 3-side gutter pouch, breather bar
• 10852171007299: Ophthalmic Drape, Incise, Clear Poly with 3-side gutter pouch, breather bar
• 10852171007282: Ophthalmic Drape, Incise two fluid pouches and breather bar Clear Poly
• 10852171007275: Ophthalmic Drape, Aperture, two fluid pouches, breather bar Clear Poly
• 10852171007268: Ophthalmic Drape, Incise with fluid pouches & breather bar Clear Poly
• 10852171007251: Ophthalmic Drape, Aperture with fluid pouches & breather bar Clear Poly
• 10852171007190: Remote Control Cover, Clear Plastic w/ tape and flap
• 10852171007183: Cover, Mayo Cover Clear Plastic, Phaco Tray Cover with Cuff 24" Wide