Duns Number:832696038
Device Description: INSTRUMENT CARE GELPI RETRACTOR TIP PROTECTOR VENTED CLEAR, 38MM 55/PACK (X 55)
Catalog Number
HS7538-CV
Brand Name
V. Mueller
Version/Model Number
HS7538-CV
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
-
Product Code
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
4595688b-6afa-465e-aff2-58f6e400989d
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 30, 2018
Package DI Number
70885403423057
Quantity per Package
55
Contains DI Package
10885403423055
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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 |