Duns Number:315018218
Device Description: Wound Retractor (With Prong), 8 3/4", (220 mm), 2 prongs, blunt, depth: 25 mm, width: 9 mm Wound Retractor (With Prong), 8 3/4", (220 mm), 2 prongs, blunt, depth: 25 mm, width: 9 mm, non-sterile, reusable
Catalog Number
BT169R
Brand Name
AESCULAP
Version/Model Number
BT169R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2020
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
GDG
Product Code Name
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
5e83dd06-563e-41f3-bc70-1391c9fa8b8c
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 24, 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 |