Duns Number:079299604
Device Description: Gauze Non Woven Sponges 2 x 2 Inch.
Catalog Number
-
Brand Name
Plastcare
Version/Model Number
RIT-2204
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
4f0b38a6-6aa1-4c0b-af90-814bfa48da3c
Public Version Date
January 22, 2020
Public Version Number
1
DI Record Publish Date
January 14, 2020
Package DI Number
D915RIT22042
Quantity per Package
25
Contains DI Package
D915RIT22041
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-