Duns Number:832696038
Device Description: DEL TOUCH MICROVASC NEEDLE HOLDER, STR, LGTH 8-5/8" (21.9CM) DUST JAW SURFACE FOR USE W/5- DEL TOUCH MICROVASC NEEDLE HOLDER, STR, LGTH 8-5/8" (21.9CM) DUST JAW SURFACE FOR USE W/5-0 SUTURE AND SMALLER
Catalog Number
CH03426
Brand Name
V. Mueller
Version/Model Number
CH03426
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
-
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
-
Product Code
FHQ
Product Code Name
HOLDER, NEEDLE, GASTROENTEROLOGIC
Public Device Record Key
facd5e52-a902-4010-a0b1-f423b43b78c8
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 02, 2018
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 |