Duns Number:830016148
Device Description: 3M™ Attest™ Instrument Protectors, 5 1/2 in x 9 1/2 in, 100 Each/Pack, 10 Packs/Case
Catalog Number
13915
Brand Name
3M™ Attest™
Version/Model Number
13915
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
LXZ
Product Code Name
Guard, instrument
Public Device Record Key
f7edb9ae-8d56-42c5-8778-7ffb0fffad69
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 18, 2021
Package DI Number
50707387792027
Quantity per Package
10
Contains DI Package
10707387792029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |