Duns Number:324868165
Device Description: Retractor (trach.), blunt, 2 prongs
Catalog Number
-
Brand Name
Hermann Medizintechnik GmbH
Version/Model Number
H118-22102
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIG
Product Code Name
RETRACTOR, ALL TYPES
Public Device Record Key
2114b6b5-60df-43ff-b05f-2c000dda4364
Public Version Date
July 21, 2022
Public Version Number
1
DI Record Publish Date
July 13, 2022
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 | 229 |
2 | A medical device with a moderate to high risk that requires special controls. | 607 |