Duns Number:007138183
Device Description: 1 Plastic carrying case, measures 9.75" X 3" X 6.5" that contains the following: (1) Roll 1 Plastic carrying case, measures 9.75" X 3" X 6.5" that contains the following: (1) Roll Athletic Tape, (3) 2" x 4.5" Bandages, (15) Bandages 3/4" x 3", (1) Tape Underwrap, (5) Gauze Pads 3" x 3", (1) Instant Cold Packs, (2) Latex Gloves, (1) Scissors, (5) Antibiotic Cream, (1) Sports Injury Care Handbook
Catalog Number
-
Brand Name
Cramer Sports Medicine Youth First Aid Kit
Version/Model Number
112100
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
5ca62911-ad8f-45c0-9846-d0d38086f4c3
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
Package DI Number
20311960740306
Quantity per Package
6
Contains DI Package
00311960740302
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |