FDA.reportPublic FDA data

LAG SCREW SHEATH

Primary DI
00887868023194
Brand
LAG SCREW SHEATH
Company
Biomet Orthopedics, LLC
Model
2112-01-300
Catalog number
211201300
Published
2020-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWDSTARTER, BONE SCREW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWDStarter, Bone ScrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868023194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868023194008878680231948878680231940887868023194

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731134752Hintermann Series VILEX LLCHWD2025-09-17
00840019968867Dakota ALIF Plate SystemPRECISION SPINE, INC.HWD2025-03-13
00840180529270General InstrumentsALPHATEC SPINE, INC.HWD2024-08-01
B07315K0140200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
B07315K0160200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
00887868570940Distal Screw SheathBiomet Orthopedics, LLCHWD2023-08-15
00887868570049Distal ScrewBiomet Orthopedics, LLCHWD2023-06-13
00887868570124Lag Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570148Affixus®Biomet Orthopedics, LLCHWD2023-06-13
00887868570155Anti-Rotation Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570162Anti-Rotation Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570179Anti-Rotation Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570186Lag Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570193Lag Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570230Lag Screw TapBiomet Orthopedics, LLCHWD2023-06-13
00887868570247Distal Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00844856069756ArsenalALPHATEC SPINE, INC.HWD2023-05-13
00190376477954AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477961AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477978AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477985AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00885556864869Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864876Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864883Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864890Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864906Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
04026575182572LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-27
04026575046768Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-20
04026575395521SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-16
04026575347698LINK Instruments - Fixation instrumentsWALDEMAR LINK GmbH & Co. KGHWD2022-12-15