Duns Number:023055619
Device Description: Scanlan® SURG-I-LOOP® silicone loops - Blue Super Maxi, 5.0x1.27 mm, 16"/40 cm long (2/pkg Scanlan® SURG-I-LOOP® silicone loops - Blue Super Maxi, 5.0x1.27 mm, 16"/40 cm long (2/pkg)
Catalog Number
1001-78A
Brand Name
Scanlan® SURG-I-LOOP® silicone loops
Version/Model Number
1001-78A
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
GAE
Product Code Name
Snare, Surgical
Public Device Record Key
b841aa8c-2f21-4b6d-991e-0d2c92b783f4
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
July 21, 2017
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 | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |