FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277378360
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
9971R
Catalog number
9971R
Device description
9971 @CTS RELIEF KIT
Published
2025-02-14
Public version status
New
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
20888277378367PackageGS14In Commercial Distribution
10888277378360PrimaryGS10
80888277378369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827737836720888277378367
1088827737836010888277378360
8088827737836980888277378369

GMDN Terms#

Term, Definition table
TermDefinition
Hand ligament surgical release instrumentA hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
4
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08
10653160394921MEDLINEDYNDC2850ADYNDC2850A2026-10-08
10653160395119MEDLINEDYNDC2762BDYNDC2762B2026-10-08
10653160395270MEDLINEDYNDC2539DDYNDC2539D2026-10-08
10884389956847MEDLINE UNITEMSL06520MSL065202015-10-15
10888277701588MEDLINEMSC9912EPMSC9912EP2025-09-24
10888277701595MEDLINEMSC9918EPMSC9918EP2025-09-24
10888277701601MEDLINEMSC9922EPMSC9922EP2025-12-10
10888277701618MEDLINEMSC9945EPMSC9945EP2025-09-24
10888277701625MEDLINEMSC9948EPMSC9948EP2025-09-24
10888277701632MEDLINEMSC9966EPMSC9966EP2025-09-24
10888277701649MEDLINEMSC99812EPMSC99812EP2025-09-24
10888277729278MEDLINEEQX9012EQX90122025-09-24
10888277729285MEDLINEEQX9022EQX90222025-09-24
10888277729292MEDLINEEQX9045EQX90452025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489753LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489760LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489777LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
00190776433666MillenniumAvalign Technologies, Inc.LXH2026-10-07
00810017915972T-Handle, 1/4" Sq, RatchetingELEVATION SPINE, INC.LXH2026-10-07
00810017915996Torque Limiting Expansion Driver Handle, 3.0NmELEVATION SPINE, INC.LXH2026-10-07
00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
B7685216080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.LXH2026-10-06
00810228161731corraCarlsmed, Inc.LXH2026-10-05
00840493441641LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
10888857615694CHESAPEAKE® Stabilization SystemVB Spine LLCLXH2026-09-23