Paneffort
GUDID 00810101310331
AAMI Level 3 Isolation Gown. Full Back, Elastic Wrist, Blue. X-Large
Paneffort, LLC
Isolation gown, single-use| Primary Device ID | 00810101310331 |
| NIH Device Record Key | 067821fe-2485-42a1-a947-8bb2bb1d1a2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paneffort |
| Version Model Number | SMGL3-FBTN-1X |
| 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 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com | |
| Phone | 1-800-518-1264 |
| service@paneffort.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810101310331 [Unit of Use] |
| GS1 | 20810101310335 [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 |
Trademark Results [Paneffort]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PANEFFORT 90238782 not registered Live/Pending |
J D UNITED MANUFACTURING CORPORATION LIMITED 2020-10-06 |
PANEFFORT 90238782 not registered Live/Pending |
Product Source Group, LLC 2020-10-06 |
 PANEFFORT 90189623 not registered Live/Pending |
J D UNITED MANUFACTURING CORPORATION LIMITED 2020-09-17 |
PANEFFORT 90189623 not registered Live/Pending |
Product Source Group, LLC 2020-09-17 |
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