Duns Number:007138183
Device Description: Gauze Pads 3” x 3”, Cramer Instant Cold Pack (large), White Athletic Tape 1-1/2”, Antibiot Gauze Pads 3” x 3”, Cramer Instant Cold Pack (large), White Athletic Tape 1-1/2”, Antibiotic Cream Individual, Alcohol Wipes, Sterile, Underwrap Beige 21 yards, 3 Foam Blister – White, Bulk Bandage 3/4” x 3”, Bulk Bandage 2” x 4”, Vytrile Examination Gloves, 3” Elastic Wrap, Black Fanny Pack Empty dimensions: 11.5” x 2.5” x 5.5”
Catalog Number
-
Brand Name
Cramer Sports Medicine Fanny Pack First Aid Kit
Version/Model Number
111005
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
a61c344b-4333-4b69-a465-969300d23934
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |