EchoGlo

GUDID 55019517086933

SMITHS MEDICAL MD, INC.

Epidural needle, non-threaded Epidural needle, non-threaded

• Primary Device ID: 55019517086933
• NIH Device Record Key: e1d9bb56-a9cf-404d-a64e-24afa9d6dfcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoGlo
• Version Model Number: 24-4119-24
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, 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: false
• 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	15019517086935 [Primary]
GS1	35019517086939 [Package]; Contains: 15019517086935; Package: BOX [10 Units]; In Commercial Distribution
GS1	55019517086933 [Package]; Contains: 35019517086939; Package: CARTON [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171968

FDA Product Code

• BSP: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-17
• Device Publish Date: 2018-03-19

On-Brand Devices [EchoGlo]

• 35019517086953: 24-4121-24
• 35019517086946: 24-4120-24
• 55019517086933: 24-4119-24
• 35019517086922: 24-4118-24
• 55019517086919: 24-4117-24
• 35019517086908: 24-4116-24
• 55019517086896: 24-4115-24
• 35019517086885: 24-4114-24
• 55019517066003: 24-4105-24
• 55019517065990: 24-4104-24
• 55019517065983: 24-4103-24
• 35019517065972: 24-4102-24
• 35019517065965: 24-4101-24
• 55019517065952: 24-4100-24