FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770416196
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
X0898
Catalog number
X0898
Device description
LOOP EAR HOUSE BILLEAU
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYQLoop, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYQLoop, WireEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770416196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770416196007577704161967577704161960757770416196

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770425723Bausch + LombN1705 93N1705 932025-08-22
00757770420797Bausch + LombN2485N24852025-08-15
00757770423194Bausch + LombE3048E30482025-08-15
00757770407712Bausch + LombX0750 21X0750 212025-08-05
00757770683505Bausch + LombSP7-72199SP7-721992025-08-05
00757770424443Bausch + LombN6065 0N6065 02025-07-29
00757770429974Bausch + LombN6065 1N6065 12025-07-29
00757770430055Bausch + LombN6065 3N6065 32025-07-29
00757770404575Bausch + LombN0902N09022025-07-28
00757770405077Bausch + LombN0964N09642025-07-28
00757770406227Bausch + LombN0950N09502025-07-28
00757770408368Bausch + LombN0965N09652025-07-28
00757770409068Bausch + LombN0986N09862025-07-28
00757770417070Bausch + LombN0958N09582025-07-28
00757770420636Bausch + LombN0970N09702025-07-28
00757770426546Bausch + LombN0982N09822025-07-28
00757770411610Bausch + LombN1685 D 1N1685 D 12025-06-03
00757770520183BLIS-X1BLIS-X12024-03-04
00757770523337BLIS-X0BLIS-X02024-03-04
00757770472222Bausch + LombMVS1083MVS10832016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275778Intrace USAPILOTIS TECH LLCJYQ2026-07-03
00757770409921Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770423514Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770433087Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00194613033118MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033125MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613046132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089160MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089313MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613106270MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613108007MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613112240MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00840343726430GEN2SURGIX MEDICAL LLCJYQ2025-06-16
00190776401160MillenniumAvalign Technologies, Inc.JYQ2025-06-10
00194613089320MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
00194613107994MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
10840306828116Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-02-12
10840306828192Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
10840306828239Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
G22313930920Medetz Surgical InstrumentsMedetz Surgical Instruments LLCJYQ2025-01-14
10840306828130Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2024-12-10
04049197309271RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197312486RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321419RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321457RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321464RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197474399RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197477796RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
00887482112892Symmetry Guilford-WrightASPEN SURGICAL PRODUCTS, INC.JYQ2024-08-12