Wealy® RELI® SS3ML20G101

GUDID 20386120009135

Safety Syringe w/ Ndl, 3ML, 20G x 1"

MYCO MEDICAL SUPPLIES INC.

Metered-delivery hypodermic syringe

• Primary Device ID: 20386120009135
• NIH Device Record Key: bb78e95c-34ac-4715-9cb7-c24264acfcad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wealy® RELI®
• Version Model Number: SS3ML20G101
• Catalog Number: SS3ML20G101
• Company DUNS: 879187821
• Company Name: MYCO MEDICAL SUPPLIES 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 3 Milliliter
• Needle Gauge: 20 Gauge
• Total Volume: 3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386120009131 [Primary]
GS1	10386120009138 [Package]; Contains: 00386120009131; Package: Inner Carton [100 Units]; In Commercial Distribution
GS1	20386120009135 [Package]; Contains: 10386120009138; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141640

FDA Product Code

• MEG: Syringe, Antistick

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Wealy® RELI®]

• 20386120009289: Retractable Safety Syringe 5ML 23G X 1"
• 20386120009272: Retractable Safety Syringe 3ML 23G X 1 1/4 "
• 20386120009265: Retractable Safety Syringe 3ML 22G X 1 1/4 "
• 20386120009258: Retractable Safety Syringe 3ML 21G X 1 1/4 "
• 20386120009241: Retractable Safety Syringe 1ML 29G x 1/2"
• 20386120009234: Retractable Safety Syringe 1ML 26G x 5/8"
• 20386120009227: Retractable Safety Syringe 1ML 25G x 1"
• 20386120009210: Retractable Safety Syringe 10ML 23G X 1.5"
• 20386120009197: Safety Syringe w/ Ndl, 10ML, 25G x 1.5"
• 20386120009180: Safety Syringe w/ Ndl, 3ML, 22G 1.5"
• 20386120009173: Safety Syringe w/ Ndl, 3ML, 22G x 1"
• 20386120009166: Safety Syringe w/ Ndl, 3ML, 21G x 1.5"
• 20386120009159: Safety Syringe w/ Ndl, 3ML, 21G x 1"
• 20386120009142: Safety Syringe w/ Ndl, 3ML, 20G x 1.5"
• 20386120009135: Safety Syringe w/ Ndl, 3ML, 20G x 1"
• 20386120009128: Safety Syringe w/ Ndl, 1ML, 27G x 0.5"
• 20386120009111: Safety Syringe w/ Ndl, 1ML, 25G x 5/8"
• 20386120009104: Safety Syringe w/ Ndl, 10ML, 22G x 1.5"
• 20386120009098: Safety Syringe w/ Ndl, 10ML, 22G x 1"
• 20386120009081: Safety Syringe w/ Ndl, 10ML, 21G x 1.5"
• 20386120009074: Safety Syringe w/ Ndl, 10ML, 21G x 1"
• 20386120009067: Safety Syringe w/ Ndl, 5ML, 27G x 1.5"
• 20386120009050: Safety Syringe w/ Ndl, 5ML, 25G x 1.5"
• 20386120009043: Safety Syringe w/ Ndl, 10ML, 20G x 1.5"
• 20386120009036: Safety Syringe w/ Ndl, 5ML, 22G x 1.5"
• 20386120009029: Safety Syringe w/ Ndl, 5ML, 22G x 1"
• 20386120009012: Safety Syringe w/ Ndl, 5ML, 21G x 1.5"
• 20386120009005: Safety Syringe w/ Ndl, 5ML, 21G x 1"
• 20386120008992: Safety Syringe w/ Ndl, 5ML, 20G x 1.5"
• 20386120008985: Safety Syringe w/ Ndl, 5ML, 20G x 1"
• 20386120008978: Safety Syringe w/ Ndl, 3ML, 27G x 0.5"
• 20386120008961: Safety Syringe w/ Ndl, 3ML, 25G x 5/8"
• 20386120008954: Safety Syringe w/ Ndl, 3ML, 25G x 1.5"
• 20386120008947: Safety Syringe w/ Ndl, 3ML, 25G x 1"
• 20386120008930: Safety Syringe w/ Ndl, 3ML, 23G x 1.5"
• 20386120008923: Safety Syringe w/ Ndl, 3ML, 23G x 1"
• 20386120008916: Safety Syringe w/ Ndl, 10ML, 20G x 1"
• 10386120013012: RELI® Wealy® Safety Insulin Syringe w/ Ndl, 1ML, 30G x 0.3125", 100ea/bx (retractable)
• 10386120013005: RELI® Wealy® Safety Insulin Syringe w/ Ndl, 1ML, 29G x 0.3125", 100ea/bx (retractable)