Duns Number:315304071
Device Description: ESOPHAGOSCOPE-TUBE ID 8.1X6.1MM model Wolf, OD 9.6x7.6mm, TL 394mm, with fixed distal lig ESOPHAGOSCOPE-TUBE ID 8.1X6.1MM model Wolf, OD 9.6x7.6mm, TL 394mm, with fixed distal light carrier, graduated, reusable
Catalog Number
8256.49
Brand Name
NA
Version/Model Number
825649
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EOX
Product Code Name
ESOPHAGOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
582dcc90-719d-426b-a9df-1002e81f7ee4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |