FDA.reportPublic FDA data

Intacs Inspection Gauge

Primary DI
00850048576025
Brand
Intacs Inspection Gauge
Company
ADDITION TECHNOLOGY, INC.
Model
KV10732
Device description
The Inspection Gauge, 0.9 mm is used as a reference to inspect the concentricity and planarity of the 0.9 mm CW and CCW Corneal Separators prior to each Intacs Corneal Implants surgery.
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
00850048576025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048576025008500485760258500485760250850048576025

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
00850048576018Intacs Corneal Separator, CCW, 0.9mmKV10730-22023-06-13
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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