FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925007246
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
OL10-0A
Device description
OPER LAP 10mm 0 AUTOCLAVE
Published
2016-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K945266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945266000OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESOptus, Inc.1995-02-23GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925007246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007246008219250072468219250072460821925007246

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28