Duns Number:001292192
Device Description: SYRINGE ALRG SFTYGLD 1ML W/NDL 26X3/8 IB
Catalog Number
305951
Brand Name
BD SafetyGlide
Version/Model Number
305951
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K992734,K992734,K992734
Product Code
MEG
Product Code Name
SYRINGE, ANTISTICK
Public Device Record Key
a97e3b44-6721-4d49-abee-cda5f6a679f3
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50382903059510
Quantity per Package
40
Contains DI Package
30382903059516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |