FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770636280
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SP7-66053
Catalog number
SP7-66053
Device description
S2050 21D BIPOLAR FCPS-DISC
Published
2025-11-14
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
HQRApparatus, Cautery, Radiofrequency, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQRApparatus, Cautery, Radiofrequency, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770636280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770636280007577706362807577706362800757770636280

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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
00757770430772Bausch + LombBausch & Lomb IncorporatedHQR2024-11-21
04049539100498DIATHERMY BIPOLAR CABLECarl Zeiss Meditec AGHQR2022-04-25
04049539100504DIATHERMY FORCEPSCarl Zeiss Meditec AGHQR2022-04-25
00757770423606Bausch + LombBausch & Lomb IncorporatedHQR2021-05-10
00781096115747Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115754Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115822Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115839Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115846Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115853Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115860Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115877Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115884Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115891Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115907Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115914Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115921Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115938Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115945Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115952Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115969Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115976Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115983Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116003Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116010Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116027Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116034Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116041Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116058Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116065Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25