Duns Number:008124539
Device Description: Packing Strip, Plain, Sterile, 1" x 5 yd. (25.4mm x 4.6m)
Catalog Number
-
Brand Name
Packing Strip
Version/Model Number
3403
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
K012816,K012816
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
ef855b7e-2c9c-40ae-a9b3-327390a9f99e
Public Version Date
May 03, 2022
Public Version Number
1
DI Record Publish Date
April 25, 2022
Package DI Number
00616784340333
Quantity per Package
12
Contains DI Package
00616784340326
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |