FDA.reportPublic FDA data

Formby Cerumen Hook & Probe, 178mm

Primary DI
05060411986923
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
424066509
Device count
1
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
true
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
05060411985339Cervical Biopsy Punch1CBR10412021-11-09
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

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Primary DI, Brand, Company table
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05010058078307InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058178304InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058078314InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05010058178311InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05060411986916Formby 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
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00887482113684Symmetry HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-12
09421901970895Rosen Inserter ADEPT MEDICAL LIMITEDJYH2024-04-23
09421902825224Adept Medical Cerumen Management KitADEPT MEDICAL LIMITEDJYH2024-04-19
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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
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