FDA.reportPublic FDA data

CARBO

Primary DI
06973169040887
Brand
CARBO
Company
Wujiang City ShenLing Medical Device Co.,Ltd
Model
CT1-3605
Device description
Classic Series CT1 Blister Pack with tube
Published
2024-11-16
Public version status
Update
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
K002411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002411000SHENLING ACUPUNCTURE NEEDLESShenling Medical Device Co., Ltd.2000-12-12MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973169040887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973169040887069731690408876973169040887

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
654613546
Device count
1
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
B491AZ112151AcuZoneAZ 1-1215AZ 1-12152017-12-21
B491AZ112301AcuZoneAZ 1-1230AZ 1-12302017-12-21
B491AZ112401AcuZoneAZ 1-1240AZ 1-12402017-12-21
B491AZ114151AcuZoneAZ 1-1415AZ 1-14152017-12-21
B491AZ114301AcuZoneAZ 1-1430AZ 1-14302017-12-21
B491AZ114401AcuZoneAZ 1-1440AZ 1-14402017-12-21
B491AZ116151AcuZoneAZ 1-1615AZ 1-16152017-12-21
B491AZ116301AcuZoneAZ 1-1630AZ 1-16302017-12-21
B491AZ116401AcuZoneAZ 1-1640AZ 1-16402017-12-21
B491AZ118151AcuZoneAZ 1-1815AZ 1-18152017-12-21
B491AZ118301AcuZoneAZ 1-1830AZ 1-18302017-12-21
B491AZ118401AcuZoneAZ 1-1840AZ 1-18402017-12-21
B491AZ118501AcuZoneAZ 1-1850AZ 1-18502017-12-21
B491AZ120151AcuZoneAZ 1-2015AZ 1-20152017-12-21
B491AZ120301AcuZoneAZ 1-2030AZ 1-20302017-12-21
B491AZ120401AcuZoneAZ 1-2040AZ 1-20402017-12-21
B491AZ120501AcuZoneAZ 1-2050AZ 1-20502017-12-21
B491AZ120601AcuZoneAZ 1-2060AZ 1-20602017-12-21
B491AZ12155AcuZoneAZ-1215AZ-12152017-12-21
B491AZ1221001AcuZoneAZ 1-22100AZ 1-221002017-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00807689000365LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000372LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000389LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000396LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000402LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000419LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000426LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000433LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000440LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000457LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000488LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000495LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000501LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000518LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000525LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000532LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000549LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000556LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000563LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000570LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000587LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000594LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23