Duns Number:105932508
Device Description: Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-214 Gem-Scope, Adult, Pink, Late Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-214 Gem-Scope, Adult, Pink, Latex Free, Breast Cancer Chest piece: 60-840-210-HP 2.5 V Standard Otoscope w/specula: 60-402-210-1 Penlight, Disposable, Pink, With Pupil Gauge, Single: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-310 Utility scissors 5.5", stainless steel with neon pink handle: Nurse Kit Pocket Organizer, White, Latex Free: 2 Velcro Tab, Fuchsia, Latex Free: 3D Pedometer: Tracks steps, aerobic steps, distance, calories burned. With 7 day memory and clock
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
80-510-214-BC-OTO-L
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
-
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
ERA
Product Code Name
Otoscope
Public Device Record Key
8fcf113a-677a-4163-9d04-a91967056432
Public Version Date
September 23, 2022
Public Version Number
4
DI Record Publish Date
October 03, 2018
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 | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |