Duns Number:015272206
Device Description: Machat LASIK lid speculum, 3 1/8'', adult size, 14.5mm open V-wire blades, nasal approach, Machat LASIK lid speculum, 3 1/8'', adult size, 14.5mm open V-wire blades, nasal approach, adjustable thumb-screw tension
Catalog Number
8088E
Brand Name
Ambler Surgical
Version/Model Number
Machat LASIK lid speculum
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
HNC
Product Code Name
Specula, ophthalmic
Public Device Record Key
2999c819-8060-4289-a974-8007dbb0110e
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |