Duns Number:014464314
Device Description: Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack, Inner case 10850 Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack, Inner case 10850003355549 - Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack,Outer case00850003355535 - DRAPE 29694 STERILE CU STEALTH AUTOGUIDE / Control Unit Drape, PE with Elastic Bands 25cm x 100cm - 9.8"x39.4", 15 each00850003355528 - DRAPE 31304 STERILE TU STEALTH AUTOGUIDE / Targeting Unit Drape, PE adapters 50cm x 100cm - 19"x39.4", 15 each
Catalog Number
9736245
Brand Name
Medtronics
Version/Model Number
9736245
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
3b9bba17-4920-47ad-a3d2-de5f9f756244
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
November 14, 2019
Package DI Number
10850003355549
Quantity per Package
1
Contains DI Package
00850003355542
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 489 |