FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506089459
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
222 167-07
Catalog number
222 167-07
Device description
KNOB FOR BACKREST ADJUSTMENT ON SURGEONS STOOL 222 167
Published
2026-04-02
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
BRXStool, Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRXStool, AnesthesiaAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506089459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506089459001985060894591985060894590198506089459

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthetist's stoolA seat, usually padded and height-adjustable, intended to be occupied by anaesthesia staff during surgical procedures as an alternative to standing; it does not include support for the back or arms. It is intended to be used in operating rooms or cleanrooms and is therefore constructed so that it is easy to clean to help minimize risk of contamination.

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
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506083907ELMED INCORPORATEDELMED INCORPORATEDBRX2025-07-08
00842180148123ELMED INCORPORATEDELMED INCORPORATEDBRX2025-04-02
00842180148130ELMED INCORPORATEDELMED INCORPORATEDBRX2025-04-02
00850020301249RelianceHAAG-STREIT USA, INC.BRX2020-09-09