FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770407972
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SP7-05990B
Catalog number
SP7-05990B
Device description
DILATOR 1.5MM
Published
2025-08-05
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
KAKProbe, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770407972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770407972007577704079727577704079720757770407972

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. 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
09348811115829INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-04-24
09348811005106INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-03-18
00714646001535Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
10714646001532Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
00714646001627Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
09348811150448INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
04250676728609Tube probeSpiggle & Theis Medizintechnik GmbHKAK2025-10-10
04250676731982Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676731999Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732002Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732026Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732033Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740625Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740649Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740656Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740663Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740694Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740700Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740717Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
00190776409487MillenniumAvalign Technologies, Inc.KAK2025-09-02
00757770636334Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00194613044404MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613048952MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613059804MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613102227MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613106287MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01