Duns Number:529966489
Device Description: ACE Stainless Steel spring handle Singles Acupuncture Needles are sterile disposable, The ACE Stainless Steel spring handle Singles Acupuncture Needles are sterile disposable, The needle length is 25mm length , One needle with one insertion tube per sterile, individually sealed blisterpackage. Needles are secured in guide tubes with plastic holding tabs. 100 needles per box.
Catalog Number
-
Brand Name
ACE
Version/Model Number
0.30*25
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
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
1d6e58e9-23de-4a89-9c9c-bc1eff0af7f5
Public Version Date
December 14, 2018
Public Version Number
1
DI Record Publish Date
November 13, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |
| U | Unclassified | 2 |