Duns Number:832696038
Device Description: V. Mueller REPLACEMENT O' RINGS 2MM 6 O'RINGS PER BAG
Catalog Number
256.9900RU
Brand Name
V. Mueller
Version/Model Number
256.9900RU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 24, 2020
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
-
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
K974382,K974382
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
0b0a0df3-c5b1-4ab6-893e-2e4ebfa9eb91
Public Version Date
March 04, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |