DEVICE: TEWA (04251282503468)
Device Identifier (DI) Information
TEWA
CJ-Type 2275 Safe-T Sleeve
Not in Commercial Distribution
A000478
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
CJ-Type 2275 Safe-T Sleeve
Not in Commercial Distribution
A000478
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
TeWa CJ-Type 2275 Safe-T Sleeve: coated acupuncture needles with copper-wire handle|with Safe-T Sleeve guide tube|Packaging: 1 needle per blister|Size: Gauge 4(x 3.0") / 0.22 x 75 mm|Color code: pink|Sales unit: 100 pieces
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Acupuncture needle, single-use | A sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQX | Needle, Acupuncture, Single Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132896 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 8 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 75 Millimeter |
Outer Diameter: 0.22 Millimeter |
Device Record Status
43715c86-f246-4eac-a0f0-75a6d096d8d0
July 31, 2018
5
August 30, 2016
July 31, 2018
5
August 30, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
4251282503475 | 10 | 04251282503468 | 2018-07-31 | Not in Commercial Distribution | parcel |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04251282503451
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49897473150
info@asiamed.com
info@asiamed.com