USIB-0001

GUDID 07290112856678

Convenient Surgical Kit Box

UNIQA DENTAL LTD

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID07290112856678
NIH Device Record Key63794d01-f071-41ec-87d5-b26d6cd4d270
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUSIB-0001
Catalog NumberUSIB-0001
Company DUNS532098872
Company NameUNIQA DENTAL LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290112856678 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-12
Device Publish Date2024-09-04

Devices Manufactured by UNIQA DENTAL LTD

07290112853110 - NA2024-11-14 Castable sleeve for MUA D-type
07290112852236 - NA2024-09-27 Analog MUA D-type
07290112852410 - NA2024-09-18 Manual screw driver for abutments H8 Hex1.25
07290112852380 - NA2024-09-17 Manual screw driver for abutments H15 Hex1.25
07290112852717 - NA2024-09-17 Ratchet screw driver for abutments H10 Hex1.25
07290112852724 - NA2024-09-17 Ratchet screw driver for abutments H15 Hex1.25
07290112852731 - NA2024-09-17 Ratchet screw driver for abutments H7 Hex1.25
07290112852748 - NA2024-09-17 Ratchet screw driver for implants 2.4mm H10

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