FDA.reportPublic FDA data

C-Thru

Primary DI
00810045920122
Brand
C-Thru
Company
INSTRUMENT SPECIALISTS, INC.
Model
C-Thru Adult Armboard Pad
Catalog number
C-100-2
Device description
"2"" thick pad - C-Thru Adult Armboard"
Published
2020-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSETable, Operating-Room, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSETable, Operating-Room, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045920122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045920122008100459201228100459201220810045920122

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic operating table topA component of a modular operating table designed as a detachable table top to support a patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted; it might be intended to provide traction, and may have x-ray transparent features. It is often intended to be used with additional patient positioners.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041517095
Device count
1
Premarket exempt
true
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045928784Alumi-Hand PLUSKH-860-8KH-860-82023-06-08
00810045921860Alumi-Hand PLUSKH-860-SingleKH-860-Single2023-06-01
00810045920009AlumiHandLarge760-8 Single2020-07-21
00810045920016AlumiHandExtra Large761-8 Single2020-07-21
00810045920023AlumiHandExtra Large761-8 2020-07-21
00810045920030AlumiHandLarge760-8 2020-07-21
00810045921631ISIS-HooksK32702020-07-30
00810045921655ISIStainless Steel Finger Traps w/Ball ChainK-3278-BC2020-07-30
00810045921662ISIStainless Steel Finger Traps w/Ball ChainK-3280-BC2020-07-30
00810045921679ISIStainless Steel Finger Traps w/Ball ChainK-3285-BC2020-07-30
00810045921686ISIStainless Steel Finger Traps w/Ball ChainK-3290-BC2020-07-30
00810045921693ISIStainless Steel Finger TrapsK33002020-07-30
00810045921709ISIStainless Steel Finger Traps w/Ball ChainK-3300-BC2020-07-30
00810045921716ISIFree StandingNT-37002020-07-30
00810045921723ISIFree StandingNT-37502020-07-30
00810045921730ISIFree StandingNT-CF-47502020-07-30
00810045921747ISIUltra-LightUL-80002020-07-30
00810045921754ISIUltra-LightUL-80502020-07-30
00810045921778ISIUltra-LightUL-81002020-07-30
00810045921785ISIUltra-LightUL-81502020-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810057372100SchureMedSCHUERCH CORPORATIONFSE2025-10-29
00194613018436MSI Precision Specialty InstrumentsMed Saver, Inc.FSE2025-08-01
00194613121105MSI Precision Specialty InstrumentsMed Saver, Inc.FSE2025-08-01
06970283131071BETACLASSICMaquet (Suzhou) Co. LTDFSE2022-12-07
06970283131088BETACLASSICMaquet (Suzhou) Co. LTDFSE2022-11-29
04046768039599BETACLASSIC mobile operating tableMAQUET GmbHFSE2022-09-22
ESOT002021NAS & T AGFSE2022-09-15
ESOT006091NAS & T AGFSE2022-09-15
00810057373794SchureMedSCHUERCH CORPORATIONFSE2021-09-10
00810057373787SchureMedSCHUERCH CORPORATIONFSE2021-09-02
00860006920708Morzine Medical Morzine Medical LLCFSE2021-07-21
00810057371431SchureMedSCHUERCH CORPORATIONFSE2020-09-08
00810057371448SchureMedSCHUERCH CORPORATIONFSE2020-09-08
00810045921716ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921723ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921730ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921747ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921754ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921778ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921785ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921792ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921808ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921822ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921839ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921846ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045921853ISIINSTRUMENT SPECIALISTS, INC.FSE2020-07-30
00810045920092C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920108C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920115C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23
00810045920139C-ThruINSTRUMENT SPECIALISTS, INC.FSE2020-07-23