Sterile Disposable Needle Guide LNGO1619PX

GUDID 10841912101198

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 10841912101198
• NIH Device Record Key: 55d92ebc-b8bf-47da-bc5a-e296fd8fc9df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Needle Guide
• Version Model Number: 5028
• Catalog Number: LNGO1619PX
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841912101191 [Primary]
GS1	10841912101198 [Package]; Contains: 00841912101191; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973958

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-16

On-Brand Devices [Sterile Disposable Needle Guide]

• 10841912101686: 5172
• 10841912101679: 5171
• 10841912101563: 5058
• 10841912101532: 5055
• 00841912101528: 5050
• 10841912101518: 5049
• 10841912101501: 5046
• 10841912101495: 5045
• 10841912101488: 5014
• 00841912101474: 5011
• 10841912101204: 5029
• 10841912101198: 5028
• 10841912101181: 5027
• 10841912101174: 5026
• 10841912101167: 5025
• 10841912100009: 5056