SpinMedix® Absorbable Fibrous Membrane

GUDID 06975222391080

Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID06975222391080
NIH Device Record Key43ff4462-2f93-4781-90a6-c7b38167056f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpinMedix® Absorbable Fibrous Membrane
Version Model NumberZK-009
Company DUNS702939498
Company NameNingbo Guangyuan Zhixin Biological Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975222391080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

On-Brand Devices [SpinMedix® Absorbable Fibrous Membrane]

06975222391196ZK-020
06975222391189ZK-019
06975222391172ZK-018
06975222391165ZK-017
06975222391158ZK-016
06975222391141ZK-015
06975222391134ZK-014
06975222391127ZK-013
06975222391110ZK-012
06975222391103ZK-011
06975222391097ZK-010
06975222391080ZK-009
06975222391073ZK-008
06975222391066ZK-007
06975222391059ZK-006
06975222391042ZK-005
06975222391035ZK-004
06975222391028ZK-003
06975222391011ZK-002
06975222391004ZK-001

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