FDA.reportPublic FDA data

CarbonMed

Primary DI
06974405095173
Brand
CarbonMed
Company
Carbon (Shenzhen) Medical Device Co., Ltd.
Model
VE-CL01-33
Published
2026-05-26
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
IQGAdaptor, Holder, Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974405095173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974405095173069744050951736974405095173

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Regulatory Flags#

DUNS number
702328173
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
06974405095050CarbonMedVN-T01-1.2(18G)×2002026-05-26
06974405095074CarbonMedVE-C012026-05-26
06974405095104CarbonMedVenus Ultimate-Dual2026-05-26
06974405095159CarbonMedVenus Ultimate-Hepa2026-05-26
06974405095166CarbonMedVenus Ultimate-Uro2026-05-26
06974405095180CarbonMedVE-L012026-05-26
06974405095197CarbonMedVN-T01-1.2(18G)×1002026-05-26
06974405095203CarbonMedVN-T01-1.2(18G)×1502026-05-26
06974405095210CarbonMedCMBNA/18152026-05-26
06974405095227CarbonMedCMBNA/18102026-05-26
06974405097290CarbonMedVE-CL01-342026-05-26
06974405097306CarbonMedVE-CL01-352026-05-26
06974405097313CarbonMedVE-CL01-362026-05-26
06974405097320CarbonMedVE-CL01-372026-05-26
06974405097559CarbonMedVE-C022026-05-26
06974405095067CarbonMedCMBNA/18202026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095074CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405095180CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097290CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097306CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097313CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097559CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
00187207000467SealSafeAndwin ScientificIQG2025-08-14
00187207000474SealSafeAndwin ScientificIQG2025-08-14
00187207000481SealSafeAndwin ScientificIQG2025-08-14
00187207000498SealSafeAndwin ScientificIQG2025-08-14
00187207000504SealSafeAndwin ScientificIQG2025-08-14
00187207000511SealSafeAndwin ScientificIQG2025-08-14
00817771028849Celling Cardio Application KitCelling BiosciencesIQG2025-04-11
00817771029600Celling Application KitCelling BiosciencesIQG2025-04-11
00860425001620Certa Dose PALS Syringe Holder CD Acquisitions, LLCIQG2025-03-03
00614950030163ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031191ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00614950031320ACEACE SURGICAL SUPPLY CO., INC.IQG2023-12-05
00850003042305Extremity CareExtremity CareIQG2023-03-30
00612479259966McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
00612479259973McKessonMCKESSON MEDICAL-SURGICAL INC.IQG2021-12-02
38054083008173AbbVie Lightweight Vest XSABBVIE INC.IQG2021-10-19
38054083008180AbbVie Lightweight Vest SABBVIE INC.IQG2021-10-19
38054083008197AbbVie Lightweight Vest MABBVIE INC.IQG2021-10-19
38054083008203AbbVie Lightweight Vest LABBVIE INC.IQG2021-10-19
38054083008210AbbVie Lightweight Vest XLABBVIE INC.IQG2021-10-19
38054083008227AbbVie Lightweight Vest XXLABBVIE INC.IQG2021-10-19
38054083007954AbbVie Hip PackABBVIE INC.IQG2021-10-18
38054083007961AbbVie Cross Body PackABBVIE INC.IQG2021-10-18