FDA.reportPublic FDA data

HEPRO.US Instrument Table Cover

Primary DI
00854427007902
Brand
HEPRO.US Instrument Table Cover
Company
HEPRO.US INC.
Model
Single Pouch Instrument Table cover
Device description
Instrument Table Cover 1 Pouch
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854427007902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854427007902008544270079028544270079020854427007902

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

Regulatory Flags#

DUNS number
080061451
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854427007056HEPRO.US Standard Surgical Gown CaseCT - Standard Surgical Gown Spunlace2017-06-21
00854427007063HEPRO.US Reinforced Surgical Gown Case 43gsmCT - Reinforced Surgical Gown 43gsm SMMS2017-06-21
00854427007841HEPRO.US Standard Surgical Gown L 43gsm 1 PouchSingle Pouch Standard Surgical gown SMMS2017-06-20
00854427007858HEPRO.US Reinforced Surgical Gown L 43gsm Single Pouch Reinforced Surgical Gown 43gsm SMMS2017-06-20
00854427007964HEPRO.US Standard Surgical Gown 68 gsmSingle Pouch Standard Surgical Gown 68gsm2017-06-20
00854427007971HEPRO.US Reinforced Surgical Gown Single Pouch 68gsmSingle Pouch Reinforced Surgical Gown 68gsm2017-06-20
00850578007174HEPRO.US Disposable Nitrile Gloves Class 450 SmallBX - 450 Nitrile Small 2017-06-21
00850578007181HEPRO.US - Disposable Nitrile Gloves Class 400 SmallCT - 400 Nitrile Small 2017-06-21
00850578007655HEPRO.US Latex Examination Gloves Size MediumCT - Latex Exam Medium 2017-06-21
00850578007662HEPRO.US Case of 10 boxes LARGE Latex Examination GlovesCT - Latex Exam Large2017-06-21
00850578007730HEPRO.US - Latex Examination Gloves SMALL - 100 in one BoxBX Latex Exam Small2017-06-21
00850578007754HEPRO.US – Latex Examination Gloves – 100 per Box - Size MediumBX - Latex Exam Medium 2017-06-21
00850578007761HEPRO.US Latex Examination Gloves Size Large BX - Latex Exam Large 2017-06-21
00850578007785"HEPRO.US Sterile Latex Surgical Gloves 7""""BX Surgical Latex Gloves 7"""2017-06-21
00850578007792"HEPRO.US Sterile Latex Surgical Gloves 7.5""""BX Surgical Latex Gloves 7.5"""2017-06-21
00850578007822HEPRO.US Nitrile Standard Class Series 350BX - 350 Nitrile Small 2017-06-21
00850578007839HEPRO.US Nitrile Standard Class Medium Series 350 BX - 350 Nitrile Medium 2017-06-21
00850578007846HEPRO.US - Nitrile Disposable Gloves Deluxe Class 350 Non-Powdered TexturedBX - 350 Nitrile Large 2017-06-21
00850578007853HEPRO.US Nitrile Standard Class Series 350 - 1 Box 100pcsBX - 350 Nitrile XL2017-06-21
00850578007860HEPRO.US Nitrile Standard Class Series 400BX - 400 Nitrile Small 2017-06-21

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Primary DI, Brand, Company table
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