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Mediflex Deluxe Laparoscopic Instruments

Primary DI
00842102100864
Brand
Mediflex Deluxe Laparoscopic Instruments
Company
FLEXBAR MACHINE CORPORATION
Model
91311-D-I
Catalog number
91311-D-I
Device description
Deluxe Johann Fenes Grasper, 40mm Double-Action, 5mm x 36cm, Insert Only
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K974382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974382000ACKERMANN SURGICAL INSTRUMENTSAckermann Instrumente GmbH1998-04-21GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102100864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102100864008421021008648421021008640842102100864

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

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00842102116421Bookler Table Mounted Retractor Systems72072-42026-03-19
00842102116391Bookler Table Mounted Retractor Systems757072026-02-09
00842102116407Bookler Table Mounted Retractor Systems69615-102026-02-09
00842102116384StrongArm Surgical Holders and Positioners212812025-11-26
00842102114618Bookler Table Mounted Retractor Systems550122021-08-18
00842102116377Bookler Table Mounted Retractor Systems750662025-09-12
00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11
00842102116285Mini-Bookler Table Mounted Retractor Systems55016-IL2025-07-11
00842102116292Mini-Bookler Table Mounted Retractor Systems55017-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
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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
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00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
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E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28