FDA.reportPublic FDA data

Preston™

Primary DI
00884450681206
Brand
Preston™
Company
Merit Medical Systems, Inc.
Model
C
Catalog number
CD1115
Published
2026-02-03
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
DWONEEDLE, BIOPSY, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWONeedle, Biopsy, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450681203PackageGS114In Commercial Distribution
00884450681206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445068120310884450681203
00884450681206008844506812068844506812060884450681206

GMDN Terms#

Term, Definition table
TermDefinition
Bone biopsy needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.

Regulatory Flags#

DUNS number
184763290
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
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450681190Preston™Merit Medical Systems, Inc.DWO2026-08-21
G635212005MAMAWIREHISTO S.A.DWO2024-05-17
G635212007MAMAWIREHISTO S.A.DWO2024-05-17
G635212010MAMAWIREHISTO S.A.DWO2024-05-17
G635212012MAMAWIREHISTO S.A.DWO2024-05-17
G635212013MAMAWIREHISTO S.A.DWO2024-05-17
G635212015MAMAWIREHISTO S.A.DWO2024-05-17
G635312005MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312007MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312010MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312012MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312013MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635312015MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635812020BLO-KHISTO S.A.DWO2024-05-17
G635812025BLO-KHISTO S.A.DWO2024-05-17
G635911810MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810B1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810D1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DB1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DY1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810Y1MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635551210BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551210C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551215BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551215C1BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551216BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551220BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551220C1BIOCORE II MGHISTO S.A.DWO2024-05-16