FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770406791
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SP7-100227
Catalog number
SP7-100227
Device description
N1691-58 MOBILIZER 30 DG ANG
Published
2026-02-11
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
KAJMobilizer, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAJMobilizer, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770406791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770406791007577704067917577704067910757770406791

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
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
00757770406838Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00757770436231Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00840183527495BR Surgical, LLCBR Surgical, LLCKAJ2024-11-26
00887482042472Symmetry HoughASPEN SURGICAL PRODUCTS, INC.KAJ2024-08-20
00190776044602AvalignAvalign Technologies, Inc.KAJ2023-09-28
00190776320263MillenniumAvalign Technologies, Inc.KAJ2023-06-23
14026704805522PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
54026704805520PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
00842331165078Novo Surgical Inc. NOVO SURGICAL, INC.KAJ2022-11-13
00190660109691Ambler SurgicalAMBLER SURGICAL CORP.KAJ2021-01-04
10381780082439Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAJ2018-10-24
10885403010026V. MuellerSTERIS CORPORATIONKAJ2018-07-13
10885403009778V. MuellerSTERIS CORPORATIONKAJ2018-07-13