"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"

Primary DI
10810235030638
Brand
"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"
Company
MERZ NORTH AMERICA, INC.
Model
9012M0
Published
2024-10-21
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
FHRNeedle, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHRNeedle, Gastro-UrologyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810235030638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081023503063810810235030638

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810235030860US Accessory Kit8070M02026-03-05
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00757770425150Bausch + LombBausch & Lomb IncorporatedFHR2025-08-18
00190776329549MILLENNIUMAvalign Technologies, Inc.FHR2023-09-28
00190776248659AvalignAvalign Technologies, Inc.FHR2023-06-23
14026704791665PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
54026704791663PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
00827002145191CookCOOK INCORPORATEDFHR2020-10-02
00827002537408CookCOOK INCORPORATEDFHR2020-10-02
10885403205293V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205309V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205316V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403050725V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050732V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050336V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050343V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050350V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050121V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050138V. MuellerCAREFUSION 2200, INCFHR2018-08-30