Duns Number:256880576
Device Description: Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.7 Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.75"
Catalog Number
4900-STAT
Brand Name
Medicom SafeGauze
Version/Model Number
4900-STAT
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
K173196,K173196,K173196
Product Code
MGQ
Product Code Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Public Device Record Key
3b3c4d94-eecf-41cf-8155-0f526ae761c4
Public Version Date
January 31, 2022
Public Version Number
9
DI Record Publish Date
October 05, 2017
Package DI Number
20686864055086
Quantity per Package
200
Contains DI Package
10686864055089
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |