FDA.reportPublic FDA data

Duraholder

Primary DI
10687225799185
Brand
Duraholder
Company
PRECISION DYNAMICS CORPORATION
Model
Y5647877
Catalog number
PDC-DURA100/100
Device description
Duraholder, 12.5X17.5 inch 6 Pockets, 2 Rows; Instrument Holder, 100 Case
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10687225799024PrimaryGS10
10687225799185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068722579902410687225799024
1068722579918510687225799185

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, strap, belt, or clothing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008486367
Device count
100
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
true
Expiration date on label
false
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
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
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
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
10080196320516MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-05
10080196320493MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-04
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26
00190776427641MillenniumAvalign Technologies, Inc.MDM2026-08-26
00810158217409PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
00850088713626PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
04054462913602evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913619evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913626evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913909evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913916evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913923evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913947evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913978evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913985evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913992evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914364evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914388evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914395evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914418evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914425evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914814evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914845evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914852evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914906evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914975evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914982evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914999evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915002evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915019evonosevonos GmbH & Co. KGMDM2026-08-25