FDA.reportPublic FDA data

BEST

Primary DI
00853508002263
Brand
BEST
Company
Lacey Manufacturing Company, LLC
Model
1587-05
Catalog number
1587-05
Device description
Sheathed Bayonet Surgical Knife
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
HTSKnife, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853508002263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853508002263008535080022638535080022630853508002263

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
00853508002249BEST PAK Access Needle PK1004PK10042023-06-15
00853508002256BEST PAK Access Needle PK1005PK10052023-06-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434182MillenniumAvalign Technologies, Inc.HTS2026-10-09
06974940307236endophixSuzhou Endophix Co., Ltd.HTS2026-06-23
20653405990366Infinity™Conmed CorporationHTS2026-06-10
20653405990373Infinity™Conmed CorporationHTS2026-06-10
20653405990380Infinity™Conmed CorporationHTS2026-06-10
20653405990397Infinity™Conmed CorporationHTS2026-06-10
20653405990403Infinity™Conmed CorporationHTS2026-06-10
20653405990410Infinity™Conmed CorporationHTS2026-06-10
00192896122796McIlwraith Bistouri KnifeSONTEC INSTRUMENTS, INC.HTS2026-03-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
10888277392687MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-04-17
00853508002621BESTLacey Manufacturing Company, LLCHTS2025-03-25
10080196392582MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-22
10080196392636MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392643MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392667MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392564MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392571MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392588MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392595MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392601MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392618MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392625MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392632MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392649MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392656MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392663MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21