Duns Number:103169095
Device Description: INSTRUMENT TRANSPORT BAG 20'' x 22'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/HIGH LEVEL INSTRUMENT TRANSPORT BAG 20'' x 22'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/HIGH LEVEL DISINFECTED LABEL - 25 BAGS PER CARRIER
Catalog Number
-
Brand Name
INSTRUMENT TRANSPORT BAG
Version/Model Number
ITB2022-H
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
0149b89d-8a05-48c4-bf51-bdda9035c1b2
Public Version Date
November 01, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2020
Package DI Number
10843356102649
Quantity per Package
8
Contains DI Package
00843356102642
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 |