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 50mm length. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with plastic holding tabs. 100 needles per box.
Catalog Number
-
Brand Name
ACE
Version/Model Number
0.35*50
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
0ae59832-9e18-41fa-abec-891282a33ece
Public Version Date
August 22, 2019
Public Version Number
1
DI Record Publish Date
August 14, 2019
Package DI Number
16972011712108
Quantity per Package
10000
Contains DI Package
06972011712101
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |