SmarTemp® S337

GUDID M595S3370

Ultralight A1 SmarTemp® Split 50ml. Cartridge

PARKELL, INC.

Dental crown/bridge resin, temporary

• Primary Device ID: M595S3370
• NIH Device Record Key: 7bd58e3e-a2d1-4ad1-bda6-b7d4fc680f5c
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SmarTemp®
• Version Model Number: S337
• Catalog Number: S337
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S3370 [Primary]

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-29
• Device Publish Date: 2016-09-23

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