FDA.reportPublic FDA data

Tech Medical Services

Primary DI
00851695005449
Brand
Tech Medical Services
Company
TECHMEDICAL SERVICES, INC.
Model
TMPH-2000
Device description
Straight Wireless Probe Cover
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851695005446PackageGS110In Commercial Distribution
00851695005449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085169500544610851695005446
00851695005449008516950054498516950054490851695005449

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
556093219
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851695005869Tech Medical ServicesTM1412021-06-25
00851695005579Tech Medical ServicesTM11002021-06-25
00851695005012Tech Medical ServicesPS60002016-09-13
00851695005487Tech Medical ServicesTMPH-20022016-09-13
00851695005258Tech Medical ServicesUSP5002016-10-13
00851695005272Tech Medical ServicesTM3001I2021-06-27
00851695005746Tech Medical ServicesTM3000W2021-06-27
00851695005760Tech Medical ServicesTM3000T2021-06-27
00851695005791Tech Medical ServicesTM3001T2021-06-27
00851695005098Tech Medical ServicesTM20002016-09-13
00851695005104Tech Medical ServicesTM20012016-09-13
00851695005111Tech Medical ServicesTM20022016-09-13
00851695005128Tech Medical ServicesTM3000I2016-09-13
00851695005180Tech Medical ServicesTM3001W2016-09-13
00851695005067Tech-Medical ServicesTM1022021-05-03
00851695005142Tech-Medical ServicesTM65012021-06-26
00851695005197Tech-Medical ServicesTM102NS2021-06-26
00851695005203Tech-Medical ServicesTM1522NS2021-06-26
00851695005210Tech-Medical ServicesTM6000NS2021-06-26
00851695005227Tech-Medical ServicesTM65002021-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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