Duns Number:733853373
Device Description: HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injec HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following• Peptic Ulcers• Dieulafoy Lesions• Mallory-Weiss Tears• Bleeding Polyp Stalks• Arteriovenous Malformations (AVMs)• AngiomataThe HS1 also has irrigation capability. Any other use is not recommended.
Catalog Number
7-HS1-001
Brand Name
Croma
Version/Model Number
Slypseal Flex
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
KNS
Product Code Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Public Device Record Key
87bddad4-ddb2-42fa-a4d7-78d2129c17d1
Public Version Date
July 30, 2021
Public Version Number
2
DI Record Publish Date
December 31, 2020
Package DI Number
05060359560216
Quantity per Package
5
Contains DI Package
05060359560223
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |