Dissecting & Access Balloon Trocar

GUDID 16955797774027

Unimicro Medical Systems (ShenZhen) Co., Ltd.

Laparoscopic access cannula, single-use
Primary Device ID16955797774027
NIH Device Record Key6f6e5fc2-4b34-419e-8dfc-c3f50c23907c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDissecting & Access Balloon Trocar
Version Model NumberUNTD-C1210
Company DUNS421327368
Company NameUnimicro Medical Systems (ShenZhen) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106955797774020 [Primary]
GS116955797774027 [Package]
Contains: 06955797774020
Package: [1 Units]
In Commercial Distribution
GS136955797774021 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-11
Device Publish Date2025-09-03

Devices Manufactured by Unimicro Medical Systems (ShenZhen) Co., Ltd.

16955797710704 - Bladeless Trocar2025-09-11
16955797714016 - Visible Trocar2025-09-11
16955797715044 - Hasson Trocar2025-09-11
16955797760020 - Auto-locking Trocar2025-09-11
16955797760044 - Auto-locking Trocar2025-09-11
16955797760068 - Auto-locking Trocar2025-09-11
16955797760082 - Auto-locking Trocar2025-09-11
16955797761027 - Bladeless Trocar2025-09-11

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