FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867090507
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1377C-07
Catalog number
AR-1377C-07
Device description
7MM CANN DIL 23MM BIO-COMP SCRW
Published
2018-05-03
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
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
00888867090507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867090507008888670905078888670905070888867090507

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867417229Arthrex®AR-9096A-14-30LAR-9096A-14-30L2026-07-22
00888867417236Arthrex®AR-9096A-14-30RAR-9096A-14-30R2026-07-22
00888867417250Arthrex®AR-9096A-14-32LAR-9096A-14-32L2026-07-22
00888867417274Arthrex®AR-9096A-14-32RAR-9096A-14-32R2026-07-22
00888867417281Arthrex®AR-9096A-14-34LAR-9096A-14-34L2026-07-22
00888867417298Arthrex®AR-9096A-14-34RAR-9096A-14-34R2026-07-22
00888867417304Arthrex®AR-9096A-14-36LAR-9096A-14-36L2026-07-22
00888867417311Arthrex®AR-9096A-14-36RAR-9096A-14-36R2026-07-22
00888867417328Arthrex®AR-9096A-14-38LAR-9096A-14-38L2026-07-22
00888867417335Arthrex®AR-9096A-14-38RAR-9096A-14-38R2026-07-22
00888867417342Arthrex®AR-9096A-14-40LAR-9096A-14-40L2026-07-22
00888867417359Arthrex®AR-9096A-14-40RAR-9096A-14-40R2026-07-22
00888867417366Arthrex®AR-9096A-14-42LAR-9096A-14-42L2026-07-22
00888867417373Arthrex®AR-9096A-14-42RAR-9096A-14-42R2026-07-22
00888867417380Arthrex®AR-9096A-14-44LAR-9096A-14-44L2026-07-22
00888867417397Arthrex®AR-9096A-14-44RAR-9096A-14-44R2026-07-22
00888867417403Arthrex®AR-9096A-14-46LAR-9096A-14-46L2026-07-22
00888867417410Arthrex®AR-9096A-14-46RAR-9096A-14-46R2026-07-22
00888867280502Arthrex®ABS-4080DABS-4080D2018-06-22
00888867084032Arthrex®ABS-10067ABS-100672017-02-15

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00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17