FDA.reportPublic FDA data

Duraholder

Primary DI
10687225799031
Brand
Duraholder
Company
PRECISION DYNAMICS CORPORATION
Model
Y5647878
Catalog number
PDC-DURA102/100
Device description
Duraholder, 12.5X17.25 inch 6 Pockets, 2 Rows with Slits; Instrument Holder, 100 Case
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
10687225799031PrimaryGS10
10687225799192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068722579903110687225799031
1068722579919210687225799192

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
10687225799048DuraholderY5647879PDC-DURA300/1002024-01-16
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
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
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00198506092428ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00840456202104JMUJMU DENTAL, INCMDM2026-07-27
00840456215760JMUJMU DENTAL, INCMDM2026-07-27
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22