FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770475223
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
ET8216 TL
Catalog number
ET8216 TL
Device description
SCISSORS VERTICAL LOW GLARE
Published
2026-04-30
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
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770475223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770475223007577704752237577704752230757770475223

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770425723Bausch + LombN1705 93N1705 932025-08-22
00757770420797Bausch + LombN2485N24852025-08-15
00757770423194Bausch + LombE3048E30482025-08-15
00757770407712Bausch + LombX0750 21X0750 212025-08-05
00757770683505Bausch + LombSP7-72199SP7-721992025-08-05
00757770424443Bausch + LombN6065 0N6065 02025-07-29
00757770429974Bausch + LombN6065 1N6065 12025-07-29
00757770430055Bausch + LombN6065 3N6065 32025-07-29
00757770404575Bausch + LombN0902N09022025-07-28
00757770405077Bausch + LombN0964N09642025-07-28
00757770406227Bausch + LombN0950N09502025-07-28
00757770408368Bausch + LombN0965N09652025-07-28
00757770409068Bausch + LombN0986N09862025-07-28
00757770417070Bausch + LombN0958N09582025-07-28
00757770420636Bausch + LombN0970N09702025-07-28
00757770426546Bausch + LombN0982N09822025-07-28
00757770411610Bausch + LombN1685 D 1N1685 D 12025-06-03
00757770520183BLIS-X1BLIS-X12024-03-04
00757770523337BLIS-X0BLIS-X02024-03-04
00757770472222Bausch + LombMVS1083MVS10832016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437725MilleniumAvalign Technologies, Inc.HNF2026-10-20
0084009620518325ga DEX Stiff Curved Horizontal ScissorsKATALYST SURGICAL LLCHNF2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsKATALYST SURGICAL LLCHNF2026-10-07
G223M1122750Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2026-10-01
04059453161765Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-09-30
05060480407480Scissors EnucleationBLINK MEDICAL LIMITEDHNF2026-09-25
00840319759431Hayden MedicalHayden Medical, Inc.HNF2026-09-04
00190776419103MillenniumAvalign Technologies, Inc.HNF2026-08-23
B382SD9037751020Surgical DirectSurgical Direct, Inc.HNF2026-08-07
G22312349490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2026-08-03
00190776422431MillenniumAvalign Technologies, Inc.HNF2026-07-31
00192896123564Castroviejo Corneal ScissorsSONTEC INSTRUMENTS, INC.HNF2026-07-27
00190776405816MillenniumAvalign Technologies, Inc.HNF2026-07-26
00190776421892MillenniumAvalign Technologies, Inc.HNF2026-07-23
00190776403904MillenniumAvalign Technologies, Inc.HNF2026-07-22
00190776397135MillenniumAvalign Technologies, Inc.HNF2026-07-16
04059453161574Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-06-03
04251047920554Vannas Capsulotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047921278Metzenbaum ScissorsA1 Medical GmbHHNF2026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936395Vitrectomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936432Gerten Iridectomy ScissorA1 Medical GmbHHNF2026-05-29
G346EA4018GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-04-23
G2231349550Ophthalmic ScissorsMedetz Surgical Instruments LLCHNF2026-04-09
09348811004192INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
09348811004260INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
G346EA40SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-10-29
G346EA0823GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-09-29