FDA.reportPublic FDA data

AGUPUNT IPEN

Primary DI
18437016482336
Brand
AGUPUNT IPEN
Company
AGU PUNT SL
Model
A1009BE
Device description
Physiotherapy needles
Published
2022-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003748000TIANXIESuzhou Tianyi Acupuncture Instruments Co., Ltd.2001-01-26MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437016482339PrimaryGS10
18437016482336Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437016482339084370164823398437016482339
1843701648233618437016482336

GMDN Terms#

Term, Definition table
TermDefinition
Dry-needling needleA sterile, thin, non-hollow, sharply-pointed metallic instrument intended for use during a dry-needling procedure to treat various musculoskeletal, nervous and/or pain symptoms. It is typically used as part of a physiotherapy treatment regime, and involves introducing the needle percutaneously into the myofascial layer with some manipulation; no medication or extrinsic energy is involved. It is typically supplied in a protective sheath. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
476185710
Device count
200
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437016482285AGUPUNT IPENA1007DE2022-04-27
08437016482292AGUPUNT IPENA1008CE2022-04-27
08437016482308AGUPUNT IPENA1008BE2022-04-27
08437016482315AGUPUNT IPENA1009E2022-04-27
08437016482322AGUPUNT IPENA1008AE2022-04-27
08437016482339AGUPUNT IPENA1009BE2022-04-27
08437016482407AGUPUNT APSA1037PC2022-04-27
08437016482414AGUPUNT APSA1010PC2022-04-27
08437016482421AGUPUNT APSA1037BPC2022-04-27
08437016482438AGUPUNT APSA1044PC2022-04-27
08437016482445AGUPUNT APSA1038PC2022-04-27
08437016482452AGUPUNT APSA1043PC2022-04-27
08437016482469AGUPUNT APSA1042PC2022-04-27
08437016482476AGUPUNT APSA1045PC2022-04-27
08437016482483AGUPUNT APSA1040PC2022-04-27
08437016482490AGUPUNT APSA1042BPC2022-04-27
08437016482506AGUPUNT APSA1042CPC2022-04-27
08437016482513AGUPUNT APSA1041PC2022-04-27
08437016482520AGUPUNT APSA1045PS2022-04-27
08437016482537AGUPUNT APSA1040PS2022-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10