FDA.reportPublic FDA data

QuickDraw

Primary DI
00850008316012
Brand
QuickDraw
Company
PARADIGM BIODEVICES INC
Model
988-1200
Device description
QuickDraw Bone Harvester, 12mm
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
10850008316019PackageGS12In Commercial Distribution
20850008316016PackageGS15In Commercial Distribution
30850008316013PackageGS120In Commercial Distribution
00850008316012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000831601910850008316019
2085000831601620850008316016
3085000831601330850008316013
00850008316012008500083160128500083160120850008316012

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephine, reusableAn 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
Length230Millimeter
Width12Millimeter

Contacts#

Phone, Email table
PhoneEmail
8886987778info@paradigmbiodevices.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008316142VisiCORE988-0800SK988-0800SK2023-11-01
00850008316029QuickDraw988-10002019-07-01
00850008316036QuickDraw988-1000S2019-07-01
00850008316050QuickDraw988-1000SK2019-07-01
30850008316013QuickDraw988-12002019-07-01
30850008316020QuickDraw988-10002019-07-01
30850008316037QuickDraw988-1000S2019-07-01

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Primary DI, Brand, Company table
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08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16