Duns Number:198227881
Device Description: Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Sigmoidoscopes with Obturators (#32410 15 mm x 15 cm, #32820 19 mm x 25 cm, #37023 23 mm x 7 cm), 30 cm Suction Tube (#30130), Insufflation Bulb (#30200), Fiber-Optic Light Head (#36019), Light Handle with 3.0 ft/0.9 m Cord (#73211), Power Transformer with 5.0
Catalog Number
35303
Brand Name
Welch Allyn, Inc.
Version/Model Number
901075
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
KDM
Product Code Name
SIGMOIDOSCOPE, RIGID, NON-ELECTRICAL
Public Device Record Key
de3e26b9-1a90-4b04-bcd5-1429c709a6ba
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |