FDA.reportPublic FDA data

QuickDraw

Primary DI
30850008316037
Brand
QuickDraw
Company
PARADIGM BIODEVICES INC
Model
988-1000S
Device description
QuickDraw Bone Harvester, 10mm short
Published
2019-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10850008316033PackageGS12In Commercial Distribution
20850008316030PackageGS120In Commercial Distribution
30850008316037PackageGS15In Commercial Distribution
00850008316036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000831603310850008316033
2085000831603020850008316030
3085000831603730850008316037
00850008316036008500083160368500083160360850008316036

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

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
00850008316050QuickDraw988-1000SK2019-07-01
30850008316013QuickDraw988-12002019-07-01
30850008316020QuickDraw988-10002019-07-01

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