PeelPro®

GUDID D6870088000FG2

PeelPro® Self-Sealing Sterilization Pouch 2.75 x 10 (70mm x 254mm) Box of 200

Sultan Healthcare Inc

Sterilization packaging, single-use

• Primary Device ID: D6870088000FG2
• NIH Device Record Key: ad07765e-2ff3-40e2-8b75-ab824b1f1170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeelPro®
• Version Model Number: 88000
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 200
• 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: +1(800)989-8825
• Email: xx@xx.xx

Device Dimensions

• Width: 10 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6870088000FG2 [Package]; Contains: D687880001; Package: Case [6 Units]; In Commercial Distribution
HIBCC	D687880000 [Unit of Use]
HIBCC	D687880001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953829

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

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• D6870088005FG2: PeelPro® Self-Sealing Sterilization Pouch 3.25 x 6.5 (83mm x 165mm) Box of 200
• D6870088000FG2: PeelPro® Self-Sealing Sterilization Pouch 2.75 x 10 (70mm x 254mm) Box of 200