FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770429936
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SP7-100883
Catalog number
SP7-100883
Device description
N7761 PULEC INJECTION NDL DISC
Published
2025-08-14
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
KAASet, Laryngeal Injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAASet, Laryngeal InjectionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770429936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770429936007577704299367577704299360757770429936

GMDN Terms#

Term, Definition table
TermDefinition
Vocal cord medialization implant injection needleA rigid, sharp, bevel-edged, hollow, tubular metal instrument intended to be used for injection of a vocal cord medialization implant, in gel form, into the vocal cord without direct visualization. It is typically curved to enable navigation of the pharynx; it is not intended to be used with an endoscope. This is a reusable device intended to be sterilized prior to use.

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
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
00757770415083Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770420094Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770421541Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770428441Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770434756Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770436200Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770457861Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00860009975156Endocraft LLCEndocraft, LLCKAA2023-07-06