FDA.reportPublic FDA data

US Accessory Kit

Primary DI
00810235030860
Brand
US Accessory Kit
Company
MERZ NORTH AMERICA, INC.
Model
8070M0
Device description
One Needle, One female to female luer lock connector, and one, 3mL Syringe
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810235030860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810235030860008102350308608102350308600810235030860

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028147846
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810235030877US Rigid Needle with Support Cannula- Double Bevel9010M02026-03-05
00810235030884US Rigid Injection Needle with Huber Point9001M02026-03-05
00810235030846Prolaryn Gel 1.0 cc2026-02-24
00810235030853Prolaryn Plus1.0 cc2026-02-24
10810235030638"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"9012M02024-10-21
10810235030645Coaptite8005M02024-10-15
M2138700M05Belotero Balance8700M02014-09-17
M2139022M1X205"K-Pack II Needle 27 GA x 0.75"" T.W. (0,4 x 20mm)"9022M1X202022-12-08
08714729804796Coaptite8005P10M00689030002014-09-17
M2138044M0K55Prolaryn Plus Injectable Implant8044M0K52015-10-28
M2138063M0K15Radiesse (+) Lidocaine1.5cc Injectable Implant8063M0K12015-08-19
M2138063M0K25Radiesse (+) Lidocaine8063M0K22016-09-09
M2138067M0K15Radiesse (+) Lidocaine 0.8cc Injectable Implant8067M0K12015-08-19
M2138069M0K15Radiesse Moderate Fill 0.8cc8069M0K12014-09-17
M2138071C0K15Radiesse Volume Advantage 1.5cc8071C0K12016-03-30
M2138071M0H15Radiesse Injectable Implant1.5cc8071M0H12016-06-24
M2138071M0K15Radiesse Volume Advantage 1.5cc8071M0K12014-09-17
M2138071M0K25Radiesse Volume Advantage8071M0K22016-09-09
M2138602M0K55Prolaryn Gel Injectable Implant8602M0K52015-10-28
00186295000342DeScribe Transparent PFD Patch50358382017-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592512WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592529WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592550WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592567WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08