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 100mm 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
0.40*125
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
9e643578-7d0a-49b2-bd80-f7d52f0c9f1f
Public Version Date
August 23, 2019
Public Version Number
1
DI Record Publish Date
August 15, 2019
Package DI Number
16972011712214
Quantity per Package
10000
Contains DI Package
06972011712217
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 |