FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770413867
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E2488
Catalog number
E2488
Device description
NEEDLE FASCIA WRIGHT
Published
2025-08-18
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
FHRNeedle, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHRNeedle, Gastro-UrologyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770413867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770413867007577704138677577704138670757770413867

GMDN Terms#

Term, Definition table
TermDefinition
Eye spud/needleA hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. 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
00757770425150Bausch + LombBausch & Lomb IncorporatedFHR2025-08-18
10810235030638"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"MERZ NORTH AMERICA, INC.FHR2024-10-21
00190776329549MILLENNIUMAvalign Technologies, Inc.FHR2023-09-28
00190776248659AvalignAvalign Technologies, Inc.FHR2023-06-23
14026704791665PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
54026704791663PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
00827002145191CookCOOK INCORPORATEDFHR2020-10-02
00827002537408CookCOOK INCORPORATEDFHR2020-10-02
10885403205293V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205309V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205316V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403050725V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050732V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050336V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050343V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050350V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050121V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050138V. MuellerCAREFUSION 2200, INCFHR2018-08-30