Duns Number:023904428
Device Description: Tuberculin Syringes with Safety Hypodermic Needles Glide / 1cc / PERMANENTLY ATTACHED REGU Tuberculin Syringes with Safety Hypodermic Needles Glide / 1cc / PERMANENTLY ATTACHED REGULAR WALL NEEDLE 27G x 1/2 in (100/bx, 4/cs)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
306620
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"
Yes
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
4185fee5-8c13-4c3d-977f-e3b52fcd3c2c
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
Package DI Number
20612479262786
Quantity per Package
100
Contains DI Package
10612479262772
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |