FDA.reportPublic FDA data

Amsco

Primary DI
00724995155018
Brand
Amsco
Company
STERIS CORPORATION
Model
3080-R
Catalog number
RC3
Device description
The 3080-R Remanufactured Table is a general operating table that can handle a variety of surgical specialties including urology, neurology, pediatrics, ENT and endovascular procedures.
Published
2021-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWWTABLE, OPERATING-ROOM, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWWTable, Operating-Room, PneumaticGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930493000QUANTUM 3080 SURGICAL TABLEAmerican Sterilizer Co.1993-06-22FQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995155018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995155018007249951550187249951550180724995155018

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table, electromechanicalA mobile, electrically-powered motorized table designed to be adjusted to support a patient during many types of surgical interventions. The table surface may consist of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or designed to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376678665ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678757ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678788ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678795ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678801ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678818ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678825ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678832ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376678887ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376729473ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-12-23
00190376532394ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-03-14
00190376532400ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-03-14
00190376532417ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-03-14
00190376532424ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-03-14
00190376532448ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-03-14
00190376537092ATEC A.R.M.ALPHATEC SPINE, INC.FWW2025-03-14