FDA.reportPublic FDA data

AGUPUNT IPEN

Primary DI
08437016482285
Brand
AGUPUNT IPEN
Company
AGU PUNT SL
Model
A1007DE
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
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
08437016482285PrimaryGS10
18437016482282Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437016482285084370164822858437016482285
1843701648228218437016482282

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.

Regulatory Flags#

DUNS number
476185710
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08437016482551AGUPUNT APSA1012P2022-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813038TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813052TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813076TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813090TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01