FDA.reportPublic FDA data

Coulmed

Primary DI
10810087352070
Brand
Coulmed
Company
Coulmed Products Group LLC
Model
AC1405
Catalog number
AC1405
Device description
"Two Tier Instrument Table: _x000D_Heavy Duty Top Tier (300 lbs Weight Capacity), 10° Sloped Top, Premium 5"" Casters, Solid Stainless Steel Construction _x000D_Overall Dimensions: 60""W x 30""D x 49""H _x000D_Top Tier Dimensions: 60""W x 20""D (10° Slope)"
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810087352070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081008735207010810087352070

GMDN Terms#

Term, Definition table
TermDefinition
Instrument table"A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called ""sterile area"" of the operation site and in some cases may be attached to the operating table."

Regulatory Flags#

DUNS number
047115479
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810087352605CoulmedAC28-PAC28-P2023-01-06
10810087352612CoulmedAC3300-BPAC3300-BP2023-01-06
10810087352629CoulmedAC3400-BPAC3400-BP2023-01-06
10810087352636CoulmedAC3800-BPAC3800-BP2023-01-06
10810087352643CoulmedAC3800-BP-LAC3800-BP-L2023-01-06
10810087352650CoulmedAC3800-BP-RAC3800-BP-R2023-01-06
10810087352667CoulmedAC3900-BPAC3900-BP2023-01-06
10810087350007CoulmedDI-5403DI-54032023-01-06
10810087350014CoulmedDI-5404DI-54042023-01-06
10810087350021CoulmedDI-5406DI-54062023-01-06
10810087350038CoulmedDI-5408DI-54082023-01-06
10810087350045CoulmedDI-5414DI-54142023-01-06
10810087350052CoulmedDI-5415DI-54152023-01-06
10810087350069CoulmedDI-5416DI-54162023-01-06
10810087350076CoulmedDI-5419DI-54192023-01-06
10810087350083CoulmedDI-5420DI-54202023-01-06
10810087350090CoulmedDI-5424DI-54242023-01-06
10810087350106CoulmedDI-5503DI-55032023-01-06
10810087350113CoulmedDI-6101DI-61012023-01-06
10810087350120CoulmedDI-6102DI-61022023-01-06

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Primary DI, Brand, Company table
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00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
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00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
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