FDA.reportPublic FDA data

ELMED

Primary DI
00842180172050
Brand
ELMED
Company
ELMED INCORPORATED
Model
EL-OS6085
Catalog number
EL-OS6085
Device description
WALTON CAST SPREADER. SERRATED, OVERALL LENGTH 9IN (22.9CM)
Published
2023-06-20
Public version status
New
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
00842180172050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180172050008421801720508421801720500842180172050

GMDN Terms#

Term, Definition table
TermDefinition
Cast spreader, reusableA hand-operated instrument with specially designed blades intended to separate and spread hardened plaster, i.e., plaster that has already formed a cast around a patient's limb or body part. It is designed like large forceps with flat, outer-edge serrated blades that may be exchangeable and which are wedge-shaped (thin at the working end). The blades are intended to be prised between cut plaster so that when the device handles are squeezed the cast separates. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
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
00198506091896ELMED INCORPORATEDSTE12600STE126002026-07-22
00198506091902ELMED INCORPORATED37-1008137-100812026-07-22
00198506091919ELMED INCORPORATEDSTE3375906STE33759062026-07-22
00198506091926ELMED INCORPORATEDSTE241502STE2415022026-07-22
00198506091933ELMED INCORPORATED31740-2231740-222026-07-22
00198506091940ELMED INCORPORATED23-403223-40322026-07-22
00198506091957ELMED INCORPORATEDSTE5210201A4SSSTE5210201A4SS2026-07-22
00198506091964ELMED INCORPORATEDSTE321011IVSTE321011IV2026-07-22
00198506091971ELMED INCORPORATED37001-3637001-362026-07-22
00198506091988ELMED INCORPORATED24946-3424946-342026-07-22
00198506091995ELMED INCORPORATEDSTE3219400EVSTE3219400EV2026-07-22
00198506092008ELMED INCORPORATEDSTE3219401EVSTE3219401EV2026-07-22
00198506092015ELMED INCORPORATEDB9911 FAD-CB9911 FAD-C2026-07-22
00198506092053ELMED INCORPORATEDST233051ST2330512026-07-22
00198506092060ELMED INCORPORATEDST233052ST2330522026-07-22
00198506092077ELMED INCORPORATEDST233053ST2330532026-07-22
00198506092084ELMED INCORPORATEDST233054ST2330542026-07-22
00198506092091ELMED INCORPORATEDST233055ST2330552026-07-22
00198506092138ELMED INCORPORATEDST129927ST1299272026-07-22
00198506092848ELMED INCORPORATEDST5303078ST53030782026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
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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