FDA.reportPublic FDA data

Duraholder

Primary DI
10687225799048
Brand
Duraholder
Company
PRECISION DYNAMICS CORPORATION
Model
Y5647879
Catalog number
PDC-DURA300/100
Device description
Duraholder 16x18.5 inches 6 Pockets, 2 Rows, 100 Case; Instrument Holder
Published
2024-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10687225799048PrimaryGS10
10687225799208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068722579904810687225799048
1068722579920810687225799208

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

Regulatory Flags#

DUNS number
008486367
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10687225799024DuraholderY5647877PDC-DURA100/1002024-01-16
10687225799031DuraholderY5647878PDC-DURA102/1002024-01-16
10687225799062DuraholderY5647881PDC-DURA505/1002024-01-16
10687225799079DuraholderY5647882PDC-DURA512/1002024-01-16
10687225799086DuraholderY5647883PDC-DURA702/1002024-01-16
10687225325087Gantry GuardCTG012016-07-28
10687225488560Gantry GuardSCTG012016-07-28
10687225648889Gantry Guard FlexCTG02CTG022018-04-25
10687225677865Gantry Guard Flex MiniCTG03CTG032018-04-25
10687225704615Gantry Guard FlexPSCTCVR22019-01-08
10687225704622Gantry Guard Flex MiniPSCTCVR32019-01-08
10687225799185DuraholderY5647877PDC-DURA100/1002024-01-16
10687225799192DuraholderY5647878PDC-DURA102/1002024-01-16
10687225799208DuraholderY5647879PDC-DURA300/1002024-01-16
10687225799222DuraholderY5647881PDC-DURA505/1002024-01-16
10687225799239DuraholderY5647882PDC-DURA512/1002024-01-16
10687225799246DuraholderY5647883PDC-DURA702/1002024-01-16
10687225793756PEDIATRIC URINE COLLECTORS, STERILE0500205002-00-SSB (Y5178898)2023-06-20
10687225793749PEDIATRIC URINE COLLECTORS, CLEAN0500105001-00-SCB (Y5178897)2023-06-20
10687225793596PEDIATRIC URINE COLLECTORS, STERILE0500205002-00-SSB (Y5178898)2023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
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00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701093Artisential Maryland DissectorLIVSMEDMDM2026-04-29