Primary Device ID | 08800019600152 |
NIH Device Record Key | 8a2a7d67-da43-421b-b373-605912efd7bf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Auto Ref-Keratometer HRK-8000A |
Version Model Number | HRK-8000A |
Catalog Number | HRK-8000A |
Company DUNS | 688154202 |
Company Name | Huvitz Co., Ltd. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +82314289100 |
svc@huvitz.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800019600152 [Primary] |
HKO | Refractometer, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-05-20 |
Device Publish Date | 2019-05-10 |
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