FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770498956
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E4270
Catalog number
E4270
Device description
PUTTERMAN CONSECUTIVE CDCR SE
Published
2025-08-01
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
KAQGouge, Nasal, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAQGouge, Nasal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770498956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770498956007577704989567577704989560757770498956

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
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
00192896123007Alexander Mastoid GougeSONTEC INSTRUMENTS, INC.KAQ2026-03-31
00190776392642MillenniumAvalign Technologies, Inc.KAQ2025-05-02
G586E3871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871840Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871850Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871860Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412490Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871760Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
00842962147665HNM MEDICALHNM STAINLESS, LLC.KAQ2023-04-07
00190776362232MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362249MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362256MillenniumAvalign Technologies, Inc.KAQ2023-02-22
M6335143910JEDMEDJEDMED INSTRUMENT COMPANYKAQ2023-02-03
00190776295189MillenniumAvalign Technologies, Inc.KAQ2022-12-12
00190776295196MillenniumAvalign Technologies, Inc.KAQ2022-12-12
00190776295202MillenniumAvalign Technologies, Inc.KAQ2022-12-12