Safehand EM-PFNGXL

GUDID 00810998035577

EM-PFNGL SAFEHAND GLV NITRILE EXTRA LARGE BLACK PWD FR, 3.5MIL

Winsight International Solutions, Inc.

Surgical/examination garment kit

• Primary Device ID: 00810998035577
• NIH Device Record Key: 20f92e15-c68f-497d-afc7-afc28cee2cb5
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safehand
• Version Model Number: EM-PFNGXL
• Catalog Number: EM-PFNGXL
• Company DUNS: 079694430
• Company Name: Winsight International Solutions, Inc.
• Device Count: 1000
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810998035560 [Primary]
GS1	00810998035577 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141303

FDA Product Code

• NJG: Flasher, Afterimage, Ophthalmic

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: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [Safehand]

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• 00810998039513: Safehand(PL)Glv Nitrile Powder Free Medium Blue, 1000/case F6950009
• 00810998039490: Safehand (PL) Glv Nitrile Powder Free Small Blue, 1000/case F6950008..
• 00810998035577: EM-PFNGL SAFEHAND GLV NITRILE EXTRA LARGE BLACK PWD FR, 3.5MIL
• 00810998034761: EM-PFNGL SAFEHAND GLV NITRILE LARGE BLACK PWD FR 3.5MIL
• 00810998034747: EM-PFNGM SAFEHAND GLOVE P/F NITRILE MEDIUM BLACK 3.5MIL
• 00810998034723: EM-PFNGS SAFEHAND GLOVE P/F NITRILE SMALL BLACK 3.5MIL
• 00810998039636: EM-PFNGL SAFEHAND glove NITRILE EXTRA LARGE BLACK PWD FR, 3.5MIL
• 00810998039612: M-PFNGL SAFEHAND glove NITRILE LARGE BLACK PWD FR 3.5MIL
• 00810998039599: EM-PFNGM SAFEHAND GLOVE P/F NITRILE MEDIUM BLACK 3.5MIL
• 00810998039575: EM-PFNGS SAFEHAND GLOVE P/F NITRILE SMALL BLACK 3.5MIL