Duns Number:257382580
Device Description: The easy-to-use David-Baker Retractors feature a simple, curved clamping mechanism to gent The easy-to-use David-Baker Retractors feature a simple, curved clamping mechanism to gently retract the upper eyelid while protecting sensitive scleral membranes.
Catalog Number
-
Brand Name
David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare), refurb
Version/Model Number
21-323R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 24, 2022
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
8eecbf1f-e52f-491f-b468-19147740a474
Public Version Date
March 25, 2022
Public Version Number
2
DI Record Publish Date
November 18, 2019
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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |