FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770403653
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N1685 P1
Catalog number
N1685 P1
Device description
CRUSHER FASCIA PROUD
Published
2025-08-04
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770403653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770403653007577704036537577704036530757770403653

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body extraction forcepsA hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. It is a rod with small jaws at its distal end which are controlled by pressing its handle; it may also include a magnifying lens and/or light source. This is a single-use 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
00190776421946MillenniumAvalign Technologies, Inc.GEN2026-07-23
00190776403881MillenniumAvalign Technologies, Inc.GEN2026-07-22
00190776403980MillenniumAvalign Technologies, Inc.GEN2026-07-22
00198506092138ELMED INCORPORATEDELMED INCORPORATEDGEN2026-07-22
00840183532093BR Surgical, LLCBR Surgical, LLCGEN2026-07-22
00190776400514MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403355MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403379MillenniumAvalign Technologies, Inc.GEN2026-07-21
00840183531423BR Surgical, LLCBR Surgical, LLCGEN2026-07-20
00190776402112MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776402136MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776400255MillenniumAvalign Technologies, Inc.GEN2026-07-17
B382SD9013461020Surgical DirectSurgical Direct, Inc.GEN2026-07-17
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03