FDA.reportPublic FDA data

NA

Primary DI
30810003223389
Brand
NA
Company
MICROSPECIALITIES, INC.
Model
MK-800800-10
Catalog number
MK-800800-10
Device description
MicroKeratome Blades, Laser Calibrated NIDEK minus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNOKeratome, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNOKeratome, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810003223389PackageGS110In Commercial Distribution
10810003223385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081000322338930810003223389
1081000322338510810003223385

GMDN Terms#

Term, Definition table
TermDefinition
Keratome blade, single-useA surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle-10degree

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-874-1832xx@xx.xx

Regulatory Flags#

DUNS number
013469890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30810003221040NAMK-100100MK-1001002019-02-13
30810003221057NAMK-100100-10MK-100100-102019-02-13
30810003221064NAMK-100100-20MK-100100-202019-02-13
30810003221071NAMK-100100-30MK-100100-302019-02-13
30810003221088NAMK-100100-40MK-100100-402019-02-13
30810003221095NAMK-100100+10MK-100100+102019-02-13
30810003221101NAMK-100100+20MK-100100+202019-02-13
30810003221118NAMK-101101 MK-101101 2019-02-13
30810003221125NAMK-101101-10MK-101101-102019-02-13
30810003221132NAMK-101101-20MK-101101-202019-02-13
30810003221149NAMK-101101-30MK-101101-302019-02-13
30810003221156NAMK-101101-40MK-101101-402019-02-13
30810003221163NAMK-101101+10MK-101101+102019-02-13
30810003221170NAMK-101101+20MK-101101+202019-02-13
30810003221330NAMK-200200MK-2002002019-01-03
30810003221521NAMK-300300MK-3003002019-01-03
30810003221958NAMK-500500MK-5005002019-01-03
30810003222139NAMK-600600MK-6006002019-01-03
30810003222146NAMK-600600-10MK-600600-102019-01-03
30810003222153NAMK-600600-20MK-600600-202019-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700483603138MORIAMORIA SAHNO2024-05-07
03700483603152MORIAMORIA SAHNO2024-05-07
03700483603176MORIAMORIA SAHNO2024-05-07
03700483603190MORIAMORIA SAHNO2024-05-07
03700483603213MORIAMORIA SAHNO2024-05-07
03700483603237MORIAMORIA SAHNO2024-05-07
03700483603251MORIAMORIA SAHNO2024-05-07
03700483603381MORIAMORIA SAHNO2024-05-07
03700483603404MORIAMORIA SAHNO2024-05-07
03700483603947MORIAMORIA SAHNO2024-05-07
03700483603961MORIAMORIA SAHNO2024-05-07
03700483600250MORIAMORIA SAHNO2023-12-27
00850011743997Wrench, Helical Drive, ML7MED LOGICS INCHNO2020-08-27
00850724001681ML7 MicrokeratomeMED LOGICS INCHNO2020-08-27
00850724001780Footswitch, ML7MED LOGICS INCHNO2020-08-27
00850724001803Handpiece, ML7MED LOGICS INCHNO2020-08-27
00850724001810Sterilization Tray, ML7MED LOGICS INCHNO2020-08-27
00850724001827Head, ML7, 100 MicronMED LOGICS INCHNO2020-08-27
00850724001834Head, ML7, 130 MicronMED LOGICS INCHNO2020-08-27
00850724001841Ring, ML7, 8.0mmMED LOGICS INCHNO2020-08-27
00850724001858Ring, ML7, 8.5mmMED LOGICS INCHNO2020-08-27
00850724001865Ring, ML7, 9.0mmMED LOGICS INCHNO2020-08-27
00850724001872Ring, ML7, 9.5mmMED LOGICS INCHNO2020-08-27
00850724001889Ring, ML7, 10.0mmMED LOGICS INCHNO2020-08-27
00850724001896Vacuum Handle, ML7MED LOGICS INCHNO2020-08-27
10850724001046ML7040 (Minus 20)MED LOGICS INCHNO2020-08-14
10850724001077ML7061 (Plano)MED LOGICS INCHNO2020-08-14
10850724001145ML7040 (Plano)MED LOGICS INCHNO2020-08-14
10850724001169ML7061 (Minus 30)MED LOGICS INCHNO2020-08-14
10850724001176ML7061 (Plus 10)MED LOGICS INCHNO2020-08-14