FDA.reportPublic FDA data

Disposable Trocars

Primary DI
06946480582060
Brand
Disposable Trocars
Company
Sinolinks Medical Innovation Co., Ltd.
Model
AVTB 5-100
Published
2025-07-23
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250820000Disposable TrocarsSinolinks Medical Innovation, Inc.2025-07-11GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946480582060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946480582060069464805820606946480582060

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528192598
Device count
1
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
06946480584057Disposable Skin Staplers DSSA-35-R2026-05-13
06946480584217Disposable Skin Staple Removers SRR2026-05-13
06946480584026Disposable Skin Staplers DSSA-15-W2026-03-13
06946480584040Disposable Skin Staplers DSSA-25-W2026-03-13
06946480584118Disposable Skin Staplers DSSB-15-R2026-03-13
06946480584125Disposable Skin Staplers DSSB-15-W2026-03-13
06946480584132Disposable Skin Staplers DSSB-25-R2026-03-13
06946480584149Disposable Skin Staplers DSSB-25-W2026-03-13
06946480584156Disposable Skin Staplers DSSB-35-R2026-03-13
06946480501276Disposable Circular StaplersDCS A-272025-09-04
06946480503638Disposable Linear Staplers and Reloads DLS B-60B2025-09-04
06946480510537Disposable Curved Cutter Staplers DCC B-40G2025-09-04
06946480563632Disposable Linear Staplers and ReloadsDLR 60-B2025-09-04
06946480576052Disposable Linear Cutter Staplers and Reloads DLC B-80B2025-09-04
06946480576151Disposable Linear Cutter Staplers and Reloads DCR B-80B2025-09-04
06946480584064Disposable Skin Staplers DSSA-35-W2025-09-04
06946480584163Disposable Skin Staplers DSSB-35-W2025-09-04
06946480584224Disposable Skin Staple Removers SRW2025-09-04
06946480589311Disposable Endoscopic Linear Cutter Staplers and Reloads DEC-B 602025-09-04
06946480589366Disposable Endoscopic Linear Cutter Staplers and Reloads DER B 60T2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30
B382SD13768330Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD9156321100Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD49195170Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
B382SD9039841050Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25