FDA.reportPublic FDA data

Halyard

Primary DI
10680651980073
Brand
Halyard
Company
Avanos Medical, Inc.
Model
98007
Catalog number
SIA-E10
Device description
PMP ACCESSORY EPSILON PROBE 1 CM 10
Published
2016-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651980077PackageGS110In Commercial Distribution
10680651980073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065198007730680651980077
1068065198007310680651980073

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic x-ray rulerA device used in an orthopaedic clinical setting to establish an accurate measurement of length or size related to a bone structure (i.e., length, thickness, or other aspects) when this is being viewed by the surgeon during fluoroscopy. It is a smooth-edged strip, typically made of stainless steel, that is marked in units of length (i.e., inches and/or millimetres) and includes a series of notches and holes that clearly show up on the x-ray image demonstrating the distances of the viewed bone. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
079375431
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770009148NeoMed120008812PNM-S35NC2026-07-21
00350770456096CLOG ZAPPER* with Applicator12000154520-00022019-06-21
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143906042SURGIPROSSurgipros, LLCFTY2026-07-28
00810212935539SURGIPROSSurgipros, LLCFTY2026-07-28
B382SD913261200Surgical DirectSurgical Direct, Inc.FTY2026-07-23
B382SD9132841000Surgical DirectSurgical Direct, Inc.FTY2026-07-23
10609576150064Puritan®Puritan Medical ProductsFTY2026-07-20
04719846017436CharderCHARDER ELECTRONIC CO., LTD.FTY2026-07-14
00849987000395SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001392SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001460SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001644SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001699SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987001804SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987002702SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987002733SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003037SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003044SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
00190776418724MillenniumAvalign Technologies, Inc.FTY2026-04-09
00757770413607Bausch + LombBausch & Lomb IncorporatedFTY2026-03-31
00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28