Duns Number:679894738
Device Description: Full body_Small Aperture_SMS_2 500ml bags_tent bar_Eye fold_160cmX252cm_Non-sterile_34EA/C Full body_Small Aperture_SMS_2 500ml bags_tent bar_Eye fold_160cmX252cm_Non-sterile_34EA/CS
Catalog Number
-
Brand Name
Beaver Visitec Inter
Version/Model Number
Model 60300303
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
Yes
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
HMT
Product Code Name
Drape, patient, ophthalmic
Public Device Record Key
584e10a7-6946-4cc5-a2b5-80a40af9dff3
Public Version Date
March 03, 2021
Public Version Number
1
DI Record Publish Date
February 23, 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 | 185 |
2 | A medical device with a moderate to high risk that requires special controls. | 295 |