Duns Number:809555139
Device Description: Colibri Forceps, .4mm standard 1x2 teeth, Angled 2mm from bend to tip set at 45° 6mm tying Colibri Forceps, .4mm standard 1x2 teeth, Angled 2mm from bend to tip set at 45° 6mm tying platform, Flat handle with oval cutout, 75mm total length, Stainless
Catalog Number
F238-1
Brand Name
Diamatrix
Version/Model Number
F238-1
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
ebcf5205-154c-4eb0-8e0f-4f321204eab2
Public Version Date
October 26, 2020
Public Version Number
1
DI Record Publish Date
October 16, 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 |