FDA.reportPublic FDA data

Intacs Procedure Marker

Primary DI
00850048576032
Brand
Intacs Procedure Marker
Company
ADDITION TECHNOLOGY, INC.
Model
KV10733
Device description
The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea.
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048576032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048576032008500485760328500485760320850048576032

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118496814
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
00850048576001Intacs Corneal Separator, CW, 0.9mmKV10730-12023-06-13
00850048576018Intacs Corneal Separator, CCW, 0.9mmKV10730-22023-06-13
00850048576025Intacs Inspection GaugeKV107322023-06-13
00850048576049Intacs ForcepsKV104452023-06-13
00850048576056Intacs Vacuum Centering GuideKV10478-22023-06-13
00850048576063Intacs Pocketing HookKV106062023-06-13
00850048576070Intacs Symmetric GlideKV11602023-06-13
00850048576100Intacs for Keratoconus, Symmetric 0.210 mmICI-210-15011600-210-1502023-06-13
00850048576117Intacs for Keratoconus, Symmetric 0.250 mmICI-250-15011600-250-1502023-06-13
00850048576124Intacs for Keratoconus, Symmetric 0.300 mmICI-300-15011600-300-1502023-06-13
00850048576131Intacs for Keratoconus, Symmetric 0.350 mmICI-350-15011600-350-1502023-06-13
00850048576148Intacs for Keratoconus, Symmetric 0.400 mmICI-400-15011600-400-1502023-06-13
00850048576155Intacs for Keratoconus, Symmetric 0.450 mmICI-450-15011600-450-1502023-06-13
00850048576162Intacs for Keratoconus, Asymmetric 0.210/0.350 mmICIA-210/350-15011400-210/350-1502023-06-13
00850048576179Intacs for Keratoconus, Asymmetric 0.210/0.400 mmICIA-210/400-15011400-210/400-1502023-06-13
00850048576186Intacs for Keratoconus, Asymmetric 0.210/0.450 mmICIA-210/450-15011400-210/450-1502023-06-13
00850048576193Intacs for Myopia, Symmetric 0.250 mmICI-250-15011700-250-1502023-06-13
00850048576209Intacs for Myopia, Symmetric 0.300 mmICI-300-15011700-300-1502023-06-13
00850048576216Intacs for Myopia, Symmetric 0.350 mmICI-350-15011700-350-1502023-06-13
00866304000142Intacs Sterile Vacuum Tubing7K60002023-06-13

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Primary DI, Brand, Company table
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04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
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00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
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00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
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00841668144374KatenaKATENA PRODUCTS, INC.HMR2026-03-31
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04