Spandex Advanced Kit ( 1 Standard/ 1 Large)

GUDID D2486054601

lip and cheeck retractor

HAGER WORLDWIDE, INC.

Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable

• Primary Device ID: D2486054601
• NIH Device Record Key: 5f7f5b73-2e57-4ce0-babf-77e668651f8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spandex Advanced Kit ( 1 Standard/ 1 Large)
• Version Model Number: 605460
• Company DUNS: 009277971
• Company Name: HAGER WORLDWIDE, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D2486054601 [Primary]

FDA Product Code

• EIF: ACCESSORIES, RETRACTOR, DENTAL

Sterilization

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

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

[D2486054601]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

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• D248222310 - Mini SafeDispense: 2024-04-22 Floss Holder/dispenser
• D248222360 - SafeDispense - White: 2024-04-22 Floss Holder/dispenser
• D248222380 - SafeDispense - Dual: 2024-04-22 Floss Holder/dispenser
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• D2484522210 - MetaLIFT Replacement Handle: 2023-12-15 MetaLIFT Crown and Bridge Remover replacement handle
• D2484522220 - MetaLIFT Regular Removal Instrument Replacement Part: 2023-12-15 MetaLIFT Crown and Bridge Regular Remover replacement