FDA.reportPublic FDA data

QuickDraw

Primary DI
00850008316050
Brand
QuickDraw
Company
PARADIGM BIODEVICES INC
Model
988-1000SK
Device description
QuickDraw Bone Harvester MIS Kit, 10mm short
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008316050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008316050008500083160508500083160500850008316050

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length152Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8886987778info@paradigmbiodevices.com

Regulatory Flags#

DUNS number
170751924
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008316142VisiCORE988-0800SK988-0800SK2023-11-01
00850008316012QuickDraw988-12002019-07-01
00850008316029QuickDraw988-10002019-07-01
00850008316036QuickDraw988-1000S2019-07-01
30850008316013QuickDraw988-12002019-07-01
30850008316020QuickDraw988-10002019-07-01
30850008316037QuickDraw988-1000S2019-07-01

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