FDA.reportPublic FDA data

Intacs Sterile Vacuum Tubing

Primary DI
00866304000142
Brand
Intacs Sterile Vacuum Tubing
Company
ADDITION TECHNOLOGY, INC.
Model
7K6000
Device description
Single use disposable vacuum tubing set to be used as an accessory to the Addition Technology, Inc and Kera Vision Vacuum System.
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866304000142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866304000142008663040001428663040001420866304000142

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118496814
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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

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Primary DI, Brand, Company table
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