Duns Number:830016148
Device Description: 3M™ Steri-Strip™ Reinforced Adhesive Skin Closures, R1547, 1/2 in x 4 in (12 mm x 100 mm), 3M™ Steri-Strip™ Reinforced Adhesive Skin Closures, R1547, 1/2 in x 4 in (12 mm x 100 mm), 6 Strips/Envelope
Catalog Number
R1547
Brand Name
3M™ Steri-Strip™
Version/Model Number
R1547
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
bed5c7eb-21a4-418f-9ef3-1fa8c3f11588
Public Version Date
March 16, 2021
Public Version Number
1
DI Record Publish Date
March 08, 2021
Package DI Number
30707387804689
Quantity per Package
50
Contains DI Package
00707387804688
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |