FDA.reportPublic FDA data

Formby Cerumen Hook & Probe, 178mm

Primary DI
05060411986916
Brand
Formby Cerumen Hook & Probe, 178mm
Company
DTR MEDICAL LIMITED
Model
FCH5001
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JYHExcavator, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYHExcavator, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060411986923PackageGS150In Commercial Distribution
05060411986916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060411986923050604119869235060411986923
05060411986916050604119869165060411986916

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, single-useA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a single-use device.

Regulatory Flags#

DUNS number
424066509
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060212052162Sims Uterine SoundUSH20012024-10-14
05060411980471Aspiration Cannulae 70mm Angled, 1.4mm/17G74-1231A 2024-10-14
05060411980662Aspiration Cannulae 70mm Angled, 1.2mm/18G74-1232 2024-10-14
05060411980730Aspiration Cannulae 70mm Angled, 1.0mm/19G74-1232A 2024-10-14
05060411980747Aspiration Cannulae 70mm Angled, 0.9mm/20g74-1233 2024-10-14
05060411980792Aspiration Cannulae 70mm Angled, 0.7mm/22G74-1234 2024-10-14
05060411980853Aspiration Cannulae 70mm Angled, 0.55mm/24G74-1236 2024-10-14
05060411980860Aspiration Cannulae 80mm Angled, 2.0mm/14G74-1260 2024-10-14
05060411981218Aspiration Cannulae 80mm Angled, 1.0mm/19G74-1262A 2024-10-14
05060411981225Aspiration Cannulae 80mm Angled,1.4mm/17G74-1264 2024-10-14
05060411981232Aspiration Cannulae 70mm Angled, 1.6mm/16G74-12312024-10-14
05060411981249Aspiration Cannulae 80mm Angled, 1.7mm/15G74-12652024-10-14
05060411981256Aspiration Cannulae 80mm Angled, 2.5mm/13G74-1267 2024-10-14
05060411981263Aspiration Cannulae 80mm Angled, 3.0mm/11G74-12682024-10-14
05060411981270Aspiration Cannulae 100mm Angled, 3.0mm/11G74-1297 2024-10-14
05060411981386Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end74-2009 2024-10-14
05060411981560Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060411981577Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
05060411981799Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012P 2024-10-14
05060411981805Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h74-2013 2024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770409396Bausch + LombBausch & Lomb IncorporatedJYH2025-08-18
00757770419784Bausch + LombBausch & Lomb IncorporatedJYH2025-08-18
05010058078307InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058178304InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058078314InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05010058178311InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05060411986923Formby Cerumen Hook & Probe, 178mmDTR MEDICAL LIMITEDJYH2024-10-11
00887482039489Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113332Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113752Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482114216Symmetry Paparella-HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113684Symmetry HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-12
09421901970895Rosen Inserter ADEPT MEDICAL LIMITEDJYH2024-04-23
09421902825224Adept Medical Cerumen Management KitADEPT MEDICAL LIMITEDJYH2024-04-19
00888515228092BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228108BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
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00888515228542BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228559BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228931BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229723BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229907BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229914BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515230248BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
G586E7214140Novo SurgicalNOVO SURGICAL, INC.JYH2023-12-18
00840343720353GEN2SURGIX MEDICAL LLCJYH2023-11-30
00810124530853Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyJYH2023-11-22
00810124530877Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyJYH2023-11-22
00810124530884Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyJYH2023-11-22