FDA.reportPublic FDA data

Huestis Medical Flexi-Holder

Primary DI
00085007700701
Brand
Huestis Medical Flexi-Holder
Company
HUESTIS MACHINE CORPORATION
Model
FH303
Device description
Flexi-Holder 26" Short Arm, Huestis Part # FH303
Published
2016-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IXACassette, Radiographic Film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXACassette, Radiographic FilmRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792721000HUESTIS FLEXI-HOLDERHuestis Machine Corp.1980-02-19IXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085007700701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085007700701000850077007010850077007010085007700701

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001188390
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00850077007293Huestis Medical Flexi-HolderFH303DP-122025-03-05
00850077007286Huestis Medical CollimatorCM-32211-QMI2021-04-02
00850077007279Huestis Medical CollimatorCM-3201-1022021-03-19
00850077007255Huestis Centralite Patient Positioning LaserCTL-DLL-22142021-02-18
00850077007262Huestis Centralite Patient Positioning LaserCTL-DLG-22142021-02-18
00850077007217Huestis Centralite Patient Positioning LaserDLG22021-02-04
00850077007224Huestis Centralite Patient Positioning LaserDLL22021-02-04
00850077007231Huestis Centralite Patient Positioning LaserDLL42021-02-04
00850077007248Huestis Centralite Patient Positioning LaserDLG42021-02-04
00850077007002Huestis Medical CollimatorCM-11002016-07-01
00850077007019Huestis Medical CollimatorCM-3201-0082016-07-18
00850077007026Huestis Medical CollimatorCM-32012-0082016-07-18
00850077007033Huestis Medical CollimatorCM-10032016-07-18
00850077007040Huestis Medical Flexi-HolderFH410-GE2016-07-18
00850077007057Huestis Medical CollimatorCM-3300B-0022016-07-18
00850077007064Huestis Medical CollimatorCM-32001-COV2016-07-18
00850077007071Huestis Medical Flexi-HolderFH3032017-06-19
00850077007088Huestis Medical Flexi-HolderFH303-12016-11-01
00850077007095Huestis Medical Flexi-HolderFH4102016-11-01
00850077007101Huestis Medical Flexi-HolderFH410-12016-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850077007293Huestis Medical Flexi-HolderHUESTIS MACHINE CORPORATIONIXA2025-03-05
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449413992KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415989KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
00810106410432dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410449dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410456dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410463dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410470dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410487dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410494dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410500dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410517dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410524dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410531dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410548dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410555dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410562dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410579dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410418dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
00810106410425dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
60889971033574DIRECTVIEW CR Long-Length Cassette with PQ ScreenCARESTREAM HEALTH, INC.IXA2021-06-06
00810050241236N/ADOMICO MED-DEVICE, LLCIXA2020-09-24
00810050240994NADOMICO MED-DEVICE, LLCIXA2020-09-24
60889978607334MIN-R 2 Cassette with MIN-R 2190 ScreenCARESTREAM HEALTH, INC.IXA2017-11-07
08809413810198Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810228Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810235Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810242Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01