Duns Number:007138183
Device Description: Pro Soft-Sided Athletic Trainer's Kit - Equipped- Pro Soft-Sided Athletic Trainer's Kit Pro Soft-Sided Athletic Trainer's Kit - Equipped- Pro Soft-Sided Athletic Trainer's Kit - Equipped Empty, (1) 3" Elastic Wrap , (1) Tuf-Skin, (1) PVP Pack , (1) Roll Athletic Tape , (1) Instant Cold Pack , (2) Latex Gloves , (1) Bulk Bandage Pack , (1) Skin Lube , (1) Sam Finger Splint , (1) Iso-Quin, (1) Sports Injury Handbook , (1) Zip-Cut, (1) Atomic Balm, (1) Cinder Suds, (1) Tape Underwrap , (1) Pocket Mirror , (1) Sterile Eye Wash , (10) Antibiotic Creams
Catalog Number
-
Brand Name
Cramer Sports Medicine Pro Soft-Sided Athletic Trainer's Kit - Equipped
Version/Model Number
121300
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
f2a9b3aa-9d59-4e6d-b4d7-26500727b8e4
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 |