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
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05060212050687Bruenings Tongue Depressor, 190mmBRU20012026-06-10
05060212051042Crocodile Scissors Straight, stainless steelCSS1001-S2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelCSC1001-S2026-06-10
05060212051103Crile Artery Forceps, 145mm StraightCFS2001-D2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatCFC2001-D2026-06-10
05060212051196Adson Non-Toothed Forceps 120mmADS5001-S2026-06-10
05060212051202Adson Toothed Forceps 120mmATS5001-S2026-06-10
05060212051264College Dental Forceps 160mmCDF20012026-06-10
05060212051721Clamp Cover Red (Small) 50mmCCR20312026-06-10
05060212051738Clamp Cover White (Med) 120mmCCW20412026-06-10
05060212051745Clamp Cover Blue (Large) 120mmCCB20512026-06-10
05060212052094Tischler Cervical Biopsy PunchCBT10012026-06-10
05060212052100Baby Tischler Cervical Biopsy PunchCBT1001B2026-06-10
05060212052339Cusco Specula Metal SmallCMM200S2026-06-10
05060212052346Cusco Specula Metal MediumCMM200M2026-06-10
05060212052360Cusco Specula Metal LargeCMM200L2026-06-10
05060212052629Cawthorne Hook 1.5mm 90 degree blackCTH2901-D2026-06-10
05060212052636Cawthorne Straight Point blackCTP2001-D2026-06-10
05060212053466Barron Suction Handle (3Fg)BSH20032026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060212052629Cawthorne Hook 1.5mm 90 degree blackDTR MEDICAL LIMITEDJYH2026-06-10
05060212052636Cawthorne Straight Point blackDTR MEDICAL LIMITEDJYH2026-06-10
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