FDA.reportPublic FDA data

Boston Endo Surgical Technologies LLC

Primary DI
00853508002331
Brand
Boston Endo Surgical Technologies LLC
Company
Lacey Manufacturing Company, LLC
Model
PK1012
Catalog number
PK1012
Device description
Pedicle Access Needle- NIM NAV PAK Needle Trocar
Published
2021-04-05
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
OLOOrthopedic Stereotaxic Instrument
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853508002331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853508002331008535080023318535080023310853508002331

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
958212029
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00853508002249BEST PAK Access Needle PK1004PK10042023-06-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141048072Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048089Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048096Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048102Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048126Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048133Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048140Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048157Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048171Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048225Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048232Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048249Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048256Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048263Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048270Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048287Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048294Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048300Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048317Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048324Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048331Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
M946109900N1TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System (10ea)THINK SURGICAL, INC.OLO2026-11-05
M9461100501TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee SystemTHINK SURGICAL, INC.OLO2026-11-05
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31