Duns Number:809555139
Device Description: Graefe Strabismus Hook Size # 3, Flattened from side to side, Angled 10mm from bend to tip Graefe Strabismus Hook Size # 3, Flattened from side to side, Angled 10mm from bend to tip, Flat smooth handle, 140mm total length, Stainless
Catalog Number
H185F-3
Brand Name
Diamatrix
Version/Model Number
H185F-3
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
HNQ
Product Code Name
Hook, Ophthalmic
Public Device Record Key
4ec073a6-5e07-4197-8897-44c086fae811
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
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 |