Duns Number:042823948
Device Description: ObstiHook Amnion Perforator
Catalog Number
J-OBHK-100
Brand Name
ObstiHook
Version/Model Number
G34312
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
HGE
Product Code Name
Amniotome
Public Device Record Key
e754bccb-7053-43c4-9389-0c2a1f2b0153
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 02, 2020
Package DI Number
10827002343129
Quantity per Package
100
Contains DI Package
00827002343122
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |