Duns Number:025460908
Device Description: SYR PLASTIC LOSS OF RESISTANCE, 7CC, L/S
Catalog Number
PAINLOR7LS
Brand Name
Medline
Version/Model Number
PAINLOR7LS
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
K201356,K201356
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
ecf9e15d-c974-40bf-a8fd-8abad487d8bf
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 04, 2022
Package DI Number
20193489031772
Quantity per Package
25
Contains DI Package
10193489031775
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |