Duns Number:079720472
Device Description: Single Saeed Multi-Band Ligator Barrel
Catalog Number
MBL-6-I-5B-S
Brand Name
Saeed
Version/Model Number
G26861
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2020
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)
Yes
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
MND
Product Code Name
Ligator, esophageal
Public Device Record Key
37211ed6-a15b-43cb-ad8b-d3fe0eb39eab
Public Version Date
October 15, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10827002268613
Quantity per Package
5
Contains DI Package
00827002268616
Package Discontinue Date
September 24, 2020
Package Status
Not 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 |