FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770409228
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N1705 02D
Catalog number
N1705 02D
Device description
NDL UTILITY ROSEN TYPE HOUSE
Published
2025-08-15
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
JYSPerforator, Ear-Lobe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYSPerforator, Ear-LobeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770409228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770409228007577704092287577704092280757770409228

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
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013956509Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956516Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956523Richline Greoup, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956561Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956578Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956585Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956592Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860014537103Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
04250676735539Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2023-08-30
04250381848449Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849491Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849507Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849514Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849538Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849927Politzer tympanum perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-09
04250381849934Lucae tympanum perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-09