Duns Number:027680821
Device Description: Intended Use in the operating room for a variety of functions such as pinning drapes into Intended Use in the operating room for a variety of functions such as pinning drapes into place and securing drains to drapes.
Catalog Number
-
Brand Name
Richard-Allan®Safety Pin
Version/Model Number
2203
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
533dac3e-37e6-49ff-9325-8fac3ad06695
Public Version Date
October 20, 2022
Public Version Number
4
DI Record Publish Date
June 18, 2019
Package DI Number
10887761012445
Quantity per Package
50
Contains DI Package
00887761012448
Package Discontinue Date
July 07, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |