FDA.report

NA

Primary DI
07290112850447
Brand
NA
Company
UNIQA DENTAL LTD
Model
USIC-1520
Catalog number
USIC-1520
Device description
Contra-angle driver for implants and cover screw H20 Hex2.42
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290112850447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290112850447072901128504477290112850447

GMDN Terms

TermDefinition
Screwing power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a powered screw insertion function when an appropriate screwdriver bit is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
532098872
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07290112853110NAUSCD-0001USCD-00012024-11-06
07290112852236NAUMAD-0001UMAD-00012024-09-19
07290112852410NAUSDM-1508USDM-15082024-09-10
07290112852380NAUSDM-1515USDM-15152024-09-09
07290112852717NAUSDR-1510USDR-15102024-09-09
07290112852724NAUSDR-1515USDR-15152024-09-09
07290112852731NAUSDR-1507USDR-15072024-09-09
07290112852748NAUIDR-2410UIDR-24102024-09-09
07290112852755NAUIDR-2415UIDR-24152024-09-09
07290112852762NAUIDR-2407UIDR-24072024-09-09
07290118049463NAUIDM-0063UIDM-00632024-09-09
07290118176572NAUIDR-3410UIDR-34102024-09-09
07290118176589NAUIDR-3415UIDR-34152024-09-09
07290118176596NAUIDR-3420UIDR-34202024-09-09
07290112853578NAUOTR-45551UOTR-455512024-09-04
07290112853592NAUOTR-45552UOTR-455522024-09-04
07290112853615NAUOTR-45553UOTR-455532024-09-04
07290112853639NAUOTR-45554UOTR-455542024-09-04
07290112853653NAUOTR-45555UOTR-455552024-09-04
07290112853677NAUOTR-50401UOTR-504012024-09-04

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