Duns Number:809555139
Device Description: Harms Tying Forceps, Curved shafts, Standard 6mm smooth tying platform, Set for 7-9 suture Harms Tying Forceps, Curved shafts, Standard 6mm smooth tying platform, Set for 7-9 sutures, flat handle with hole pattern, 102mm total length, Stainless Steel
Catalog Number
F885S-C
Brand Name
Diamatrix
Version/Model Number
F885S-C
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
221718e9-73f8-4aa9-95d4-1fdc41ed38d6
Public Version Date
November 18, 2020
Public Version Number
1
DI Record Publish Date
November 10, 2020
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 | 475 |
U | Unclassified | 13 |