Duns Number:025460908
Device Description: WRAP,CSR,GEMINI,36X36,ONE PLY,HEAVY WGH
Catalog Number
GEMG4136
Brand Name
Medline
Version/Model Number
GEMG4136
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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
013ec44e-ef92-4db7-b5ee-d1bc1b3257a0
Public Version Date
November 23, 2020
Public Version Number
1
DI Record Publish Date
November 13, 2020
Package DI Number
40888277338204
Quantity per Package
3
Contains DI Package
20888277338200
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 |