FDA.reportPublic FDA data

Duraholder

Primary DI
10687225799086
Brand
Duraholder
Company
PRECISION DYNAMICS CORPORATION
Model
Y5647883
Catalog number
PDC-DURA702/100
Device description
Duraholder 12.75 x 18/5 inch, 6 Pockets, 2 Rows with Slits, 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
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
10687225799086PrimaryGS10
10687225799246Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068722579908610687225799086
1068722579924610687225799246

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
10687225799048DuraholderY5647879PDC-DURA300/1002024-01-16
10687225799062DuraholderY5647881PDC-DURA505/1002024-01-16
10687225799079DuraholderY5647882PDC-DURA512/1002024-01-16
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
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27