FDA.reportPublic FDA data

None

Primary DI
16945416407030
Brand
None
Company
MEIXIN MEDICAL SUZHOU CO., LTD.
Model
AD88129
Published
2023-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16945416407030PrimaryGS10
46945416407031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1694541640703016945416407030
4694541640703146945416407031

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.

Regulatory Flags#

DUNS number
530231216
Device count
108
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16945416401007NoneMTB400E2016-11-21
16945416401014NoneMTW4002016-11-21
16945416401021NoneMTG4002016-11-21
16945416401090None5-50422016-11-21
16945416401205NoneMTB36362016-11-21
16945416401229NoneMTB400X2017-01-18
16945416401045None MT4002017-10-23
16945416401199NoneMTB4002018-08-22
16945416401212None MT400032017-10-23
16945416403032NoneMG44122023-09-30
16945416403049NoneMG44162023-09-30
16945416403117None5-199172023-09-30
16945416403124None5-199182023-09-30
16945416403155None5-199252023-09-30
16945416403179None5-199272023-09-30
16945416403193None5-199302023-09-30
16945416403230None5-199352023-09-30
16945416404022NoneMN44042023-09-30
16945416404046None5-199292023-09-30
16945416406002NoneCS54802023-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232030NASTERIS CORPORATIONBWN2026-05-26
10381780542254MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
10381780542261MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
03701602300044ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300051ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300068ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300075ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300099Velcro Strap longInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300105PURIST - Leg positioning systemInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300112PURIST / OLH - Boot S - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300129PURIST / OLH - Boot M - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300136OLH #ERDP - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300143OLH #ERD - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300150OLH #ER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300167OLH #BHA- BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300174OLH #ED - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300181OLH - DENYER PLUS - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300198OLH - DENYER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300204OLH - US/EU - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300211POP UNIVERSALInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300228OLH #ERDPInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300235OLH #ERDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300242OLH #ERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300259MP XRAYCERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300266DAA TOP 360Innovative Orthopedic Technologies AGBWN2026-01-13
03701602300273OLH #BHAInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300280OLH #BHSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300297OLH #EDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300303OLH - DENYER PLUSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300310OLH - DENYERInnovative Orthopedic Technologies AGBWN2026-01-13