FDA.reportPublic FDA data

BEST PAK Access Needle

Primary DI
00853508002249
Brand
BEST PAK Access Needle
Company
Lacey Manufacturing Company, LLC
Model
PK1004
Catalog number
PK1004
Device description
PAK Pedicle Access Needle XPAK Bevel
Published
2023-06-15
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
00853508002249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853508002249008535080022498535080022490853508002249

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
203-336-7453jim.rogers@paragonmedical.com

Regulatory Flags#

DUNS number
958212029
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853508002515BE-ST Ligament Tensioner1100403701100403702026-03-09
00853508002645BE-ST Sheathed Bayonet Surgical Knife 1587-121587-122026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife 1587-101587-102026-02-16
00853508002614BE-ST ElectroCautery Pencil 1560-031560-032025-03-25
00853508002621BEST1587-111587-112025-03-25
00853508002638Boston Endo Surgical Technologies LLC1590-111590-112025-03-25
00853508002171BEST1587-031587-032023-06-15
00853508002188BEST1587-041587-042023-06-15
00853508002218BEST PAK Access Needle PK1001PK10012023-06-15
00853508002225BEST PAK Access Needle PK1002PK10022023-06-15
00853508002232BEST PAK Access Needle PK1003PK10032023-06-15
00853508002256BEST PAK Access Needle PK1005PK10052023-06-15
00853508002263BEST1587-051587-052023-06-15
00853508002478BEST1587-061587-062023-06-15
00853508002485BEST1600-021600-022023-06-15
00853508002492BEST1587-071587-022023-06-15
00853508002508BEST1587-081587-082023-06-15
00853508002522BEST1587-091587-092023-06-15
00853508002027BEST1563-001563-002023-06-14
00853508002089BEST1587-011587-012023-06-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
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B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31