FDA.reportPublic FDA data

Huibo Medical

Primary DI
06936943411457
Brand
Huibo Medical
Company
Henan Huibo Medical Co.,Ltd.
Model
25*10mm
Device description
Medical skin stretching and secure wound-closure system comprises PP buckle, medical adhesive tape and release paper.
Published
2020-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZWExpander, Surgical, Skin Graft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936943411457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936943411457069369434114576936943411457

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closing tension deviceA sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560455084
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936943403087Huibo Medical4*30cm2020-02-26
06936943403094Huibo Medical12*15cm2020-02-26
06936943404039Huibo Medical25g2020-02-28
06936943404022Huibo Medical15g2020-01-21
06936943403100Huibo Medical6cm*8cm2020-01-20
06936943411136Huibo Medical10*10cm2020-01-21
06936943411150Huibo Medical10cm*10cm2020-01-21
06936943411471Huibo Medical10*10cm2020-01-21
06936943411488Huibo Medical10*10cm2020-01-21
06936943400598Huibo Medical10*10cm, border2020-01-21
06936943412416Huibo Medical10*10cm, borderless2020-01-21
06936943411839Huibo MedicalI-AD-S, open toe, beige2020-02-28
06936943411846Huibo MedicalI-AD-M, Beige, Open toe2020-02-28
06936943411853Huibo MedicalI-AD-L, Beige, Open toe2020-02-26
06936943472175Huibo MedicalII-AD-M2020-01-21
06936943403070Huibo Medical4*30cm2020-02-26
06936943403063Huibo Medical12*15cm2020-02-26

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Primary DI, Brand, Company table
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04049197024686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
00810006780123Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780130Mesh Ex EXSURCO MEDICAL, INC.FZW2024-03-20
00810006780147Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780154Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
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00810006780192Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780215Mesh ExEXSURCO MEDICAL, INC.FZW2024-03-20
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07540162040429Imperial Stackable StepstoolImperial Surgical LtdFZW2023-07-28
06975808860214MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
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05033955099060Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099091Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
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05033955099121Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
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00855638007156Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
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