Duns Number:015272206
Device Description: Perkins self-retaining retractor, 5'', 3 blunt prongs on left shaft, 7.0mm long, 11.0mm x Perkins self-retaining retractor, 5'', 3 blunt prongs on left shaft, 7.0mm long, 11.0mm x 25.0mm solid blade with spikes on right shaft, 80mm spread, ring handle with ratchet catch
Catalog Number
72-650
Brand Name
Ambler Surgical
Version/Model Number
Perkins self-retaining retractor
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
KAL
Product Code Name
RETRACTOR, ENT
Public Device Record Key
bfb8887e-08a7-41cd-89b0-4c740fb6dc93
Public Version Date
January 15, 2021
Public Version Number
1
DI Record Publish Date
January 07, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |