Duns Number:809555139
Device Description: Graefe Strabismus Hook Size # 2, Flattened from side to side, Angled 9mm from bend to tip, Graefe Strabismus Hook Size # 2, Flattened from side to side, Angled 9mm from bend to tip, Flat smooth handle, 140mm total length, Stainless
Catalog Number
H185F-2
Brand Name
Diamatrix Ltd.
Version/Model Number
H185F-2
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
5bdc7e2a-6a03-4996-bd9a-b81fabd1e0bd
Public Version Date
November 24, 2021
Public Version Number
1
DI Record Publish Date
November 16, 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 |