FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770520145
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E8989
Catalog number
E8989
Device description
BERDAHL GONIO PRISM STABILIZER
Published
2025-08-07
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770520145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770520145007577705201457577705201450757770520145

GMDN Terms#

Term, Definition table
TermDefinition
Flieringa ophthalmic ringA circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. This is a reusable 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
B382SD905701100Surgical DirectSurgical Direct, Inc.FHQ2026-07-23
00840183531980BR Surgical, LLCBR Surgical, LLCFHQ2026-07-22
00190776403751MillenniumAvalign Technologies, Inc.FHQ2026-07-21
00840183531720BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532475BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532499BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00190776397104MillenniumAvalign Technologies, Inc.FHQ2026-07-16
04059453084217Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-07-16
00810055258567Surgical DesignSurgical Design, Inc.FHQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.FHQ2026-06-22
00810055251544Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810055251551Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810212931654SURGIPROSSurgipros, LLCFHQ2026-06-01
00810055250721Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250738Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250745Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250752Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250783Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250790Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250806Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250813Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250820Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250844Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250851Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250882Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250905Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250912Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450028Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450035Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450066Surgical DesignSurgical Design, Inc.FHQ2026-05-29