FDA.reportPublic FDA data

None

Primary DI
16945416401199
Brand
None
Company
MEIXIN MEDICAL SUZHOU CO., LTD.
Model
MTB400
Published
2018-08-22
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
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16945416401199PrimaryGS10
46945416401190Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1694541640119916945416401199
4694541640119046945416401190

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, non-sterileA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530231216
Device count
400
Premarket exempt
true
Lot or batch
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
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
16945416406019NoneCS54902023-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918100852AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918101774AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918103037AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918141121AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918145204AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
16931918183800InvenioGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-28
30193489017742MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017759MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017766MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017773MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017780MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017797MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
B376KB100DAB0Drape KB100 SeriesKent Imaging IncPUI2026-07-21
10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08