Duns Number:038101861
Device Description: TLC Universal Retractor Stay, Low Profile, Medium, 5mm, Sharp Hook, 4-pk (Sterile, Pouched TLC Universal Retractor Stay, Low Profile, Medium, 5mm, Sharp Hook, 4-pk (Sterile, Pouched)
Catalog Number
-
Brand Name
TLC Self-Retaining Retractor Stays
Version/Model Number
ETLC103-4
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"
Yes
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
GAD
Product Code Name
Retractor
Public Device Record Key
6290695a-7937-40f4-9b88-64ad82d557e5
Public Version Date
May 10, 2021
Public Version Number
4
DI Record Publish Date
September 30, 2018
Package DI Number
00842071112042
Quantity per Package
1
Contains DI Package
00842071109516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box (TLC103-4)
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1325 |