Duns Number:689846211
Device Description: KM Needle general and hand type is general type its hair-thin shape of stainless steel wir KM Needle general and hand type is general type its hair-thin shape of stainless steel wire. It has 0.16 ~ 0.70mm body diameter and 15 ~ 135mm body length. All these components are disposable.
Catalog Number
-
Brand Name
KM NEEDLE
Version/Model Number
KMS GS0356020
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
K142920,K142920,K142920,K142920
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
6900f06a-7a47-4614-bb1c-0fbc6ba02d9b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
38800020500169
Quantity per Package
10
Contains DI Package
28800020500162
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |