FDA.reportPublic FDA data

ABS HOOK AND LOOP PAD

Primary DI
00842430115455
Brand
ABS HOOK AND LOOP PAD
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
160-0011
Catalog number
600-0016
Published
2021-02-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORCAir Filter Portable Apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORCAir Filter Portable ApparatusGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123006000AIR BARRIER SYSTEM (ABS)Nimbic Systems, Inc.2013-12-20ORC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842430115452PackageGS110In Commercial Distribution
00869284000225PreviousGS10
00842430115455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084243011545210842430115452
00869284000225008692840002258692840002250869284000225
00842430115455008424301154558424301154550842430115455

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical skin adhesive tapeA long thin band of synthetic material coated on one side with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or combination of materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
084527241
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430116261KIT, HANA SSXT MAQUET 1140 VERSION687668762023-01-17
00842430113093KIT, HANA SSXT-HIP ARTHROSCOPY UNIT687468742022-05-19
00842430103155HANA SSXT- AA THA UNIT, MOT, JP RAILS6879-16879-12022-02-14
00842430103162Hana SSXT- AA THA Unit, MOT, EU Rails6879-26879-22022-02-14
00842430111365HANA SSXT- AA THA UNIT REFURB6870R6870R2022-02-11
00842430113086HANA SSXT- AA THA UNIT687068702022-02-11
00842430114236HANA SSXT-HIP ARTHROSCOPY UNIT, LIFEHEALTHCARE IMAGE 777687368732022-02-11
00842430106484ProFx TRACTION BOOT ADAPTOR ASSY6850-276850-272019-04-02
00842430108914PATIENT TRANSFER ASSY6875-7426875-7422019-04-02
00842430106415Hana/ProFx LATERAL PERINEAL POST6850-4006850-4002018-10-17
00842430106989BUTTOCKS STRAP W/ VELCRO6977-7396977-7392018-12-07
00842430109027Avra Smart Hub Powered by BodiTrak2872-102872-102021-06-14
00842430110283AVRA HEAD SECTION 3IN STERIS 3080, 308569403AVH69403AVH2021-06-14
00842430110290AVRA BACK SECTION 3IN STERIS 3080, 308569403AVB69403AVB2021-06-14
00842430110306AVRA FOOT SECTION, 3IN, STERIS 3080, 308569403AVF69403AVF2021-06-14
00842430110641AVRA 3-PC SET 3IN STERIS 3080 308569403AVS69403AVS2021-06-14
00842430111266AVRA WIRELESS TABLET DISPLAY2872-402872-402021-06-14
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842430115738HANA DISPOSA-PULL P-POST COVERMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-05-31
00842430115448AIR BARRIER SYSTEM STERILE NOZZLEMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115462AIR BARRIER SYSTEM BLOWERMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115745ABS HOOK AND LOOP PADMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
07350101640067Sterile ShieldToul Meditech ABORC2019-12-20
07350101640050Sterile ShieldToul Meditech ABORC2019-12-20
07350101640043SteriStayToul Meditech ABORC2019-09-05
07350101640005OperioToul Meditech ABORC2019-04-08
07350101640029Sterile ShieldToul Meditech ABORC2019-02-13
00869284000249ABS Blower UnitNIMBIC SYSTEMS, INC.ORC2018-11-15
00869284000201ABS NozzleNIMBIC SYSTEMS, INC.ORC2016-10-20
00869284000232ABS NozzleNIMBIC SYSTEMS, INC.ORC2016-10-20
00869284000225ABS Velcro PadNIMBIC SYSTEMS, INC.ORC2016-10-20