FDA.reportPublic FDA data

Levó Protective Arm Sleeve

Primary DI
00842430104947
Brand
Levó Protective Arm Sleeve
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
7892
Catalog number
7892
Published
2019-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430104947PrimaryGS10
00842430116810Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430104947008424301049478424301049470842430104947
00842430116810008424301168108424301168100842430116810

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09
00842430115097SLING, REHAB SHOULDER, ABDUCTION8678672020-09-03
00842430112119IMMOBILIZER, SHOULDER, UNIVESAL,W/ STRAP146S146S2020-07-27
00842430100031Allegro Table Refurbished 120V, 60HZ6800R6800R2016-09-15
00842430104022ALUMINUM SIDE RAIL SOCKET539453942018-04-18
00842430104404PIVOTING ARM BOARD W/TEMPUR 2IN535653562018-04-18
00842430104497CMBU RADIOLUCENT DORO ADAPTER5979-3005979-3002018-05-10
00842430104503CMBU RADIOLUCENT MAYFIELD ADAPTER5979-2005979-2002018-05-10
00842430104541COUPLER II RADIOLUCENT DORO ADAPTER5873-3005873-3002018-04-26
00842430105098PIVOTING ARM BOARD W/TEMPUR 3IN535753572018-04-18
00842430105159Trios/OTS TRACTION EXTENSION SHORT5855-5785855-5782018-04-24
00842430105166Trios/OTS TRACTION EXTENSION LONG5855-1935855-1932018-04-26
00842430105357GM BOARD LEFT PAD5855-2875855-2872018-05-10
00842430105371GM BOARD RIGHT PAD5855-2865855-2862018-05-10
00842430105739Trios/OTS FOOT-END DRAPE HANGER POST5855-6175855-6172018-05-03
00842430105746Trios/OTS HEAD-END DRAPE HANGER POST5855-6155855-6152018-05-03
00842430105920PIVOTING ARM BOARD ASSY W/OUT PAD5362-65362-62018-11-09
00842430106125MTS WELL HIP FIXATION FRAME (8mm)6835-86835-82018-08-24

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