Duns Number:025460908
Device Description: SPONGE,TONSIL,DBL STRNG,XRAY,MED,1",STRL
Catalog Number
MDS78914
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS78914
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
4254a06b-b6b6-4a04-ac36-814cf62049c4
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
March 31, 2021
Package DI Number
40888277338938
Quantity per Package
20
Contains DI Package
10888277338937
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |