FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770683567
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SP7-35672
Catalog number
SP7-35672
Device description
PERKINS DUCKBILL ELEV-8MM
Published
2026-05-11
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
KADElevator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770683567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770683567007577706835677577706835670757770683567

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. 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
00757770409167Bausch + LombS2050 10SS2050 10S2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995270704V. MuellerSTERIS Deutschland GmbHKAD2026-09-25
00724995270759V. MuellerSTERIS Deutschland GmbHKAD2026-09-25
04054462905577evonosevonos GmbH & Co. KGKAD2026-08-21
04054462905584evonosevonos GmbH & Co. KGKAD2026-08-21
04054462905645evonosevonos GmbH & Co. KGKAD2026-08-21
04054462906512evonosevonos GmbH & Co. KGKAD2026-08-21
04054462906529evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907366evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907380evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907397evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907441evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907496evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907502evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907519evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907526evonosevonos GmbH & Co. KGKAD2026-08-21
04054462911462evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911479evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911486evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911493evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911936evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911943evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911950evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911967evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911998evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912001evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912018evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912032evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912674evonosevonos GmbH & Co. KGKAD2026-08-19
04054462907373evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907403evonosevonos GmbH & Co. KGKAD2026-08-18