FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770481811
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E2508
Catalog number
E2508
Device description
ORIGINAL PUTTERMAN CLAMP
Published
2024-12-30
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
HODClamp, Eyelid, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HODClamp, Eyelid, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770481811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770481811007577704818117577704818110757770481811

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid clamp, reusableA hand-held manual surgical instrument designed specifically to atraumatically grasp and hold the eyelid or isolate a portion of eyelid tissue during an ophthalmic surgical intervention (e.g., chalazion surgery, blepharostoplasty). It includes an appropriate clamping mechanism which may be one of a variety of designs (e.g., ring and disk), and may be referred to as entropion forceps, Downes lid clamp, or chalazion clamp. 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
00757770636099Bausch + LombBausch & Lomb IncorporatedHOD2026-04-30
00757770505715Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00757770505722Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00757770524426Bausch + LombBausch & Lomb IncorporatedHOD2026-04-29
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HOD2026-02-23
G2231139450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-11-05
G2231140730Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-09-05
00757770494071Bausch + LombBausch & Lomb IncorporatedHOD2025-08-15
G2231115290Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-08-11
00757770485574Bausch + LombBausch & Lomb IncorporatedHOD2025-08-08
G22312045700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-01-14
G223M12045670Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2025-01-14
00757770472277Bausch + LombBausch & Lomb IncorporatedHOD2024-11-21
G223147970530Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-09-19
G2231126320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-07-29
G22312045690Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-07-01
G223119354A0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-06-17
00840183509040BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
00840183509057BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
00840183516703BR Surgical, LLCBR Surgical, LLCHOD2024-06-03
G22312045620Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2024-05-23
G22312045660Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
G22312045670Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOD2023-08-10
00817524028157J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028164J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00817524028171J&J InstrumentsJ & J INSTRUMENTS INCHOD2023-03-01
00841668135761ERHARDT LID FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135808BAIRD CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135815DESMARRES CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07
00841668135822FRANCIS CHALAZION FORCEPSKATENA PRODUCTS, INC.HOD2022-12-07