FDA.report

ACE

Primary DI
00815005021741
Brand
ACE
Company
Wuxi Jiajian Medical Instrument Co.,Ltd.
Model
0.25*25
Device description
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 blister package. Needles are secured in guide tubes with plastic holding tabs. 100 needles per box.
Published
2017-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications

CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815005021741PrimaryGS10
01815005021741Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815005021741008150050217418150050217410815005021741
01815005021741018150050217411815005021741

GMDN Terms

TermDefinition
Acupuncture needle, single-useA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
529966489
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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06932307410418JIAJIANTENS WMPS2-12026-03-04
06932307410432JIAJIANTENStem eco basic2026-03-04
06932307410449JIAJIANWQ-10D12026-03-04
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06932307410425JIAJIANTENS WMPS6-12026-03-03
06972011718424JIAJIANCMNS6-12026-03-03
06972011718431JIAJIANCMNS6-22026-03-03
00815005021253SHUNLI0.30*502016-10-25
00815005021307SHUNLI0.16*152016-10-25
00815005021314SHUNLI0.20*152016-10-25
00815005021505Jiajianpointoselect2018-05-17
00815005021512SHUNLI0.20*302016-10-21
00815005021529SHUNLI0.25*302017-11-13
00815005021536SHUNLI0.16*302016-10-21
00815005021703ACE0.18*402017-08-29
00815005021765ACE0.18*132017-08-29
00815005021772ACE0.20*252017-08-29
00815005021789ACE0.16*132017-08-29

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