FDA.reportPublic FDA data

Rosen Inserter

Primary DI
09421901970895
Brand
Rosen Inserter
Company
ADEPT MEDICAL LIMITED
Model
NZ3461-100
Published
2024-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
09421901970895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421901970895094219019708959421901970895

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tube inserter, single-useA hand-held device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as a myringotomy tube, grommet or an aural vent tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
592534619
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421901970345NeoZolineNZ3306NZ33062016-02-25
09421901970352NeoZolineNZ3306-2NZ3306-22016-02-25
09421901970369NeoZolineNZ3309NZ33092016-02-25
09421901970376NeoZolineNZ3309-2NZ3309-22016-02-25
09421901970383NeoZolineNZ3312NZ33122016-02-25
09421901970390NeoZolineNZ3312-2NZ3312-22016-02-25
09421901970406NeoZolineNZ3321NZ33212016-02-25
09421901970413NeoZolineNZ3321-2NZ3321-22016-02-25
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionAM0460AM04602026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowAM0470AM04702026-02-09
09421902825927Arm StrapsAM0620AM06202018-05-24
09421902825491Adept Medical Femoral TableAM0300AM03002017-05-29
09421902825880IR ShieldAM0500AM05002017-11-24
09421902825941Adept Medical Drape SupportAM1000AM10002018-07-25
09421905187374Adept Medical ArmSureAM0640AM06402024-03-20
09421905187435Adept Medical STARTableDAM0140D2024-02-15
09421905187558Adept Medical Arm Support PadAAM01712022-10-13
09421905187589Adept Medical Drape SupportBAM1000B2022-10-13
09421902825712Adept Medical STARTableAM0140CAM0140C2017-05-29
09421902825934Arm Sure ShieldAM0630AM06302018-05-24

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
05060411986916Formby Cerumen Hook & Probe, 178mmDTR MEDICAL LIMITEDJYH2024-10-11
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
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
00888515228528BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228535BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
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