FDA.reportPublic FDA data

Standard Trocar

Primary DI
10851677007048
Brand
Standard Trocar
Company
STANDARD BARIATRICS, INC
Model
ST19-1
Published
2020-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K200517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200517000Standard TrocarStandard Bariatrics2020-04-09GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851677007048PackageGS16In Commercial Distribution
00851677007041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085167700704810851677007048
00851677007041008516770070418516770070410851677007041

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
091278068
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851677007102Titan SGS Bailout ChuckSBCSBC2024-07-12
10851677007109Titan SGS Bailout ChuckSBCSBC2024-07-12
00851677007140Atlas SSLR Buttress AssemblyIPN928199SSLR232024-07-10
00851677007171Standard Precision Bougie DeviceSTB38STB382024-07-03
00851677007157Titan SGS Standard Gastric StaplerSGS23R2023-10-23
00851677007164Titan SGS Standard Gastric StaplerSGS23R2023-10-23
00851677007126Standard Tapered Bougie, 38FrSTB382022-11-28
10851677007123Standard Tapered Bougie, 38FrSTB382022-11-28
00851677007058Standard BougieSB18-12020-04-27
00851677007065Standard Bougie, 38FrSB382021-08-18
00851677007119Standard Bougie HandpumpSBHP2021-12-22
00851677007133Titan SGS Standard Gastric StaplerSGS23Rb2022-06-02
10851677007116Standard Bougie HandpumpSBHP2021-12-22
00851677007072Standard Bougie, 38FrSB382021-08-18
00851677007089Titan SGS Standard Gastric StaplerSGS23R2021-08-18
00851677007096TITAN Standard Power UnitSPU012021-08-18
00851677007041Standard TrocarST19-1ST192020-04-27
10851677007055Standard BougieSB18-12020-04-27
00851677007027Standard Clamp, DisposableSCD22-12020-01-23
00851677007003Standard Clamp, Disposable SCD25-1SCD25-12017-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
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