Duns Number:103169095
Device Description: INSTRUMENT TRANSPORT BAG 12'' x 18'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/HIGH LEVEL INSTRUMENT TRANSPORT BAG 12'' x 18'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/HIGH LEVEL DISINFECTED LABEL - 100 Bags
Catalog Number
-
Brand Name
INSTRUMENT TRANSPORT BAG
Version/Model Number
ITB1218-A
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
GEJ
Product Code Name
Carrier, Ligature
Public Device Record Key
5dab12be-004e-4210-a85e-5f82d015e4ae
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
10843356102595
Quantity per Package
2
Contains DI Package
00843356102598
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 146 |