FDA.reportPublic FDA data

Preston™

Primary DI
00884450681190
Brand
Preston™
Company
Merit Medical Systems, Inc.
Model
C
Catalog number
CD1110
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10884450681197PackageGS114In Commercial Distribution
00884450681190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445068119710884450681197
00884450681190008844506811908844506811900884450681190

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00884450030301Merit Medical®Initial ReleaseK08-02374A2026-09-18
00884450101315Merit Medical®Initial ReleaseK12T-11002F2026-09-18
00884450121368Merit Medical®Initial ReleaseK04-00791B2026-09-19
00884450265260Merit Medical®Initial ReleaseK09T-10440D2026-09-18
00884450276808Merit Medical®Initial ReleaseK12T-084642026-09-18
00884450277164Merit Medical®Initial ReleaseK09T-09666F2026-09-18
00884450295854Merit Medical®Initial ReleaseK12T-094032026-09-18
00884450306628Merit Medical®Initial ReleaseK12T-02866A2026-09-18
00884450306635Merit Medical®Initial ReleaseK09T-10276A2026-09-18
00884450306642Merit Medical®Initial ReleaseK12T-03836A2026-09-18
00884450320150Merit Medical®Initial ReleaseK10T-052102026-09-18
00884450320426Merit Medical®Initial ReleaseK10T-053242026-09-18
00884450336922Merit Medical®Initial ReleaseK09T-115672026-09-18
00884450339589Merit Medical®Initial ReleaseK12T-031482026-09-18
00884450340011Merit Medical®Initial ReleaseK12T-035362026-09-18
00884450352069Merit Medical®Initial ReleaseK12T-078402026-09-18
00884450428443Merit Medical®Initial ReleaseK10-01694R2026-09-18
00884450428955Merit Medical®Initial ReleaseK09-14183A2026-09-18
00884450431740Merit Medical®Initial ReleaseK09-10388B2026-09-18
00884450432068Merit Medical®Initial ReleaseK09-07593C2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G635551410BIOCORE II MGHISTO S.A.DWO2024-05-16