Duns Number:387634079
Device Description: EDGE M is BTC ultimate concept of Multispecialty Examination and Procedure Chair. It is th EDGE M is BTC ultimate concept of Multispecialty Examination and Procedure Chair. It is the result of innovative technical and engineering solutions that enable the Professionals to perform any examination and procedure in the outpatient and/or Ambulatory Surgery Centres. EDGE M is the paramount tool that suits all clinics and private practices in any medical field.
Catalog Number
9110500
Brand Name
BTC - Medical Equipment
Version/Model Number
EDGE M
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GBB
Product Code Name
Chair, Surgical, Ac-Powered
Public Device Record Key
e363a5ca-f481-4b93-b81a-191b574098a2
Public Version Date
March 21, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2021
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 | 2 |