Duns Number:257382580
Device Description: The Skin Hook is a retractor with two sharp prongs. All non-reflective.
Catalog Number
-
Brand Name
Skin Hook Retractor (with 2 Sharp Prongs) (non glare), refurb.
Version/Model Number
28-012R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 24, 2022
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
GAD
Product Code Name
Retractor
Public Device Record Key
895c0c02-b380-423c-b0f6-3fc50074878b
Public Version Date
March 25, 2022
Public Version Number
2
DI Record Publish Date
November 15, 2019
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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |