FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770407712
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
X0750 21
Catalog number
X0750 21
Device description
FENEST'TR GUILFRD-WGHT NEW ANG
Published
2025-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JYOKnife, Ear

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770407712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770407712007577704077127577704077120757770407712

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. 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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
00757770602506Bausch + LombET6322ET63222026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462901937evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906390evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906406evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906413evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906420evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906437evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906444evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906451evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906468evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906475evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906536evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906543evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906581evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906598evonosevonos GmbH & Co. KGJYO2026-08-21
04054462900282evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901913evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901920evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901951evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901968evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906482evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906499evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906550evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906567evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906574evonosevonos GmbH & Co. KGJYO2026-08-18
04054462907533evonosevonos GmbH & Co. KGJYO2026-08-18
09348811109194INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811150257INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811109798INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-30
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11