FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506085406
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST240812SS
Catalog number
ST240812SS
Device description
Brain Spatulas, Stainless Steel, Malleable, 8”OL (200mm), 5.8mm Tip
Published
2025-09-09
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
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506085406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506085406001985060854061985060854060198506085406

GMDN Terms#

Term, Definition table
TermDefinition
Brain spatulaA hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. 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
00198506044366ELMEDST52732404EST52732404E2026-06-09
00198506091278ELMED INCORPORATED55013-10A55013-10A2026-06-09
00198506091285ELMED INCORPORATED12-53785-042T12-53785-042T2026-06-09
00198506091292ELMED INCORPORATEDSS22-5200-09ASS22-5200-09A2026-06-09
00198506091308ELMED INCORPORATEDSS22-5200-09FSS22-5200-09F2026-06-09
00198506091315ELMED INCORPORATEDSTE379670STE3796702026-06-09
00198506091322ELMED INCORPORATEDSTE379675STE3796752026-06-09
00198506091339ELMED INCORPORATEDSTESM150526JC08ISTESM150526JC08I2026-06-09
00198506091346ELMED INCORPORATEDSTE4570910STE45709102026-06-09
00198506091353ELMED INCORPORATEDSTE239935STE2399352026-06-09
00198506091360ELMED INCORPORATED37350-64C137350-64C12026-06-09
00198506091377ELMED INCORPORATEDS37520-64C1S37520-64C12026-06-09
00198506091384ELMED INCORPORATED37520-06C137520-06C12026-06-09
00198506091391ELMED INCORPORATEDS37520-06C1S37520-06C12026-06-09
00198506091407ELMED INCORPORATEDSTE122857STE1228572026-06-09
00198506091476ELMED INCORPORATED12-36-1812-36-182026-06-09
00198506091483ELMED INCORPORATED51-4080-0851-4080-082026-06-09
00198506091490ELMED INCORPORATEDSTE321202EVSTE321202EV2026-06-09
00198506091568ELMED INCORPORATED115 515/715115 515/7152026-06-08
00842180148864ELMED INCORPORATED232 412232 4122026-06-08

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