Duns Number:007928633
Device Description: Suture Boot Set Consisting of the Following: 1 x 8800-511 Short Suture Boot 3-1/2" Long, 1 Suture Boot Set Consisting of the Following: 1 x 8800-511 Short Suture Boot 3-1/2" Long, 1 x 8800-512 Medium Suture Boot 6" Long & 1 x 8800-513 Long Suture Boot 7-1/4" Long
Catalog Number
8800-570
Brand Name
Suture Boot Set
Version/Model Number
8800-570
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
GAD
Product Code Name
Retractor
Public Device Record Key
22b290f2-05c3-4656-bbfb-b8344ddf1804
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 01, 2022
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 | 2597 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |