Duns Number:543007373
Device Description: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Catalog Number
SND492
Brand Name
SOL-Guard Safety Needle
Version/Model Number
18G x 1 1/2"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190183,K190183,K190183
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
386f114f-145c-4eff-8ed5-0685845e8692
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 08, 2021
Package DI Number
16958697600007
Quantity per Package
100
Contains DI Package
06958697600000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-