Duns Number:315018218
Device Description: SMITH-BUIE Rectal Retractor, 6 1/2", (165 mm), blades 58 x 23 mm, width: 155 mm, opening w SMITH-BUIE Rectal Retractor, 6 1/2", (165 mm), blades 58 x 23 mm, width: 155 mm, opening width: 110 mm, non-sterile, reusable
Catalog Number
BV906R
Brand Name
AESCULAP
Version/Model Number
BV906R
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
FFO
Product Code Name
RETRACTOR, SELF-RETAINING
Public Device Record Key
2c28f3ba-821f-47df-8476-ddc09bcb7d8e
Public Version Date
April 28, 2020
Public Version Number
1
DI Record Publish Date
April 20, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |