FDA.reportPublic FDA data

Intacs Corneal Separator, CCW, 0.9mm

Primary DI
00850048576018
Brand
Intacs Corneal Separator, CCW, 0.9mm
Company
ADDITION TECHNOLOGY, INC.
Model
KV10730-2
Device description
The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within 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
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048576018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048576018008500485760188500485760180850048576018

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
00850048576025Intacs Inspection GaugeKV107322023-06-13
00850048576032Intacs Procedure MarkerKV107332023-06-13
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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