Paneffort

GUDID 00810101310102

AAMI Level 3 Isolation Gown. Full Back, Elastic Wrist, Blue. Regular/Large

Paneffort, LLC

Isolation gown, single-use

• Primary Device ID: 00810101310102
• NIH Device Record Key: b3c298c6-e301-48d1-9f75-aa4a27a65ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paneffort
• Version Model Number: SMGL3-FBTN-1R
• Company DUNS: 018250858
• Company Name: Paneffort, LLC
• Device Count: 100
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com
• Phone: 1-800-518-1264
• Email: service@paneffort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810101310102 [Unit of Use]
GS1	20810101310106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212717

FDA Product Code

• FYC: Gown, Isolation, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

On-Brand Devices [Paneffort]

• 00810085252726: AAMI Level 4 Ultra Reinforced Surgical Gown. Medium.
• 00810085252702: AAMI Level 4 Ultra Reinforced Surgical Gown. Small.
• 00810085252795: AAMI Level 4 Ultra Reinforced Surgical Gown. XX-Large.
• 00810085252771: AAMI Level 4 Ultra Reinforced Surgical Gown. X-Large.
• 00810085252757: AAMI Level 4 Ultra Reinforced Surgical Gown. Large.
• 00810085252689: AAMI Level 3 Standard Surgical Gown. XX-Large.
• 00810085252665: AAMI Level 3 Standard Surgical Gown. X-Large.
• 00810085252641: AAMI Level 3 Standard Surgical Gown. Regular/Large.
• 00810085252627: AAMI Level 3 Standard Surgical Gown. Medium.
• 00810085252603: AAMI Level 3 Standard Surgical Gown. Small.
• 10810101310482: Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Band. Regular/L
• 20810101310076: AAMI Level 2 Isolation Gown. Full Back, Elastic Wrist, Blue. X-Large.
• 20810101310069: AAMI Level 2 Isolation Gown. Full Back, Elastic Wrist, Blue. Regular/Large.
• 20810101310519: Disposable Anti-Fog Face Shield. Full-Length, Foam Head Protection, Elastic Head Band
• 20810101310557: ASTM Level 2 3-Ply Procedure Mask with Earloops. Blue.
• 00810101310850: Chemotherapy Isolation Gown. Poly-Coated, Full Back, Tie Neck, Elastic Wrist, Blue. Regular/Larg
• 00810101311031: Disposable Lab Coat. Zipper Front, Traditional Collar, Elastic Wrist, Blue. X-Large
• 00810101311024: Disposable Lab Coat. Zipper Front, Traditional Collar, Elastic Wrist, Blue. Regular/Large
• 00810101310935: Disposable Scrub Set. Short Sleeve Scrub Shirt. Elastic Waist Pant with Pockets, Blue. Large
• 10810101310451: Premium Lab Jacket. Disposable, Snap Front, Knit Cuffs & Collar, Blue. Regular/Large
• 10810101310444: Premium Lab Jacket. Disposable, Snap Front, Knit Cuffs & Collar, Blue. Medium
• 10810101310406: Premium Lab Jacket. Disposable, Snap Front, Knit Cuffs & Collar, Blue. X-Large
• 00810101310966: Disposable Scrub Set. Short Sleeve Scrub Shirt. Elastic Waist Pant with Pockets, Blue. X-Large
• 00810101310959: Disposable Scrub Set. Short Sleeve Scrub Shirt. Elastic Waist Pant with Pockets, Blue. Small
• 00810101310942: Disposable Scrub Set. Short Sleeve Scrub Shirt. Elastic Waist Pant with Pockets, Blue. Medium
• 00810101310911: Disposable Scrub Set. Short Sleeve Scrub Shirt. Elastic Waist Pant with Pockets, Blue. XX-Large
• 00810101310331: AAMI Level 3 Isolation Gown. Full Back, Elastic Wrist, Blue. X-Large
• 00810101310102: AAMI Level 3 Isolation Gown. Full Back, Elastic Wrist, Blue. Regular/Large