Duns Number:109903521
Device Description: ACCUPASS STR SHUTL MONOFIL -SEE72201361
Catalog Number
72200721
Brand Name
ACCU-PASS
Version/Model Number
72200721
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
Yes
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
cc61da76-5a26-49df-be83-322c373b126f
Public Version Date
December 04, 2020
Public Version Number
6
DI Record Publish Date
October 05, 2015
Package DI Number
23596010576075
Quantity per Package
10
Contains DI Package
03596010576071
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |