FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770406371
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N0470 2
Catalog number
N0470 2
Device description
HOOK EAR DAY SMALL
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
JYLHook, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770406371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770406371007577704063717577704063710757770406371

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
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G043615080BEARBear-Ent, LLCJYL2026-01-19
G043615090BEARBear-Ent, LLCJYL2026-01-19
G043615100BEARBear-Ent, LLCJYL2026-01-19
09348811108364INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
09348811149886INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
04250676734891MENTIO disposable ear curette cottonSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250676734907MENTIO Disposable Nasal SpeculaSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250381821503Gillies skin hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676710017HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676711625ForkSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676705259Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676705266Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716071Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716088Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676738394HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676735560Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735577Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735584Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735591Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735607Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739582Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739599Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739605Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739612Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739629Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676745248Universal scissorsSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
00757770406265Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770410125Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770412631Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770413836Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05