FDA.reportPublic FDA data

OHKI Tunneler

Primary DI
00883475950076
Brand
OHKI Tunneler
Company
CHARMANT INC.
Model
30-0501
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883475950076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883475950076008834759500768834759500760883475950076

GMDN Terms#

Term, Definition table
TermDefinition
Tunnelling forcepsA hand-held manual surgical instrument designed to be used to open a soft tissue plane (tunnelling) and to pull an object, typically a tube implant or other device, back through the tunnel. It is made of metal and typically has an elongated, slender, scissors-like design with two blades that close like jaws and ring handles. It may be used during rib/rib cage internal fixation procedures. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693742728
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883475708523Multi Purpose Forceps37-00352023-09-18
00883475953930Paddle tip Manipulator37-00802023-09-18
00883475953947Ball tip Manipulator37-00812023-09-18
00883475953299MS Round-Crescent-Flat22-01BNJP2024-08-01
00883475953305MS Round-Crescent-Flat22-01BNKP2024-08-01
00883475953312MS Round-ST-Flat22-02BNIP2024-08-01
00883475953329MS Round-ST-Flat22-02BNKP2024-08-01
00883475953411MS Round-ST-CV22-03BNIP2024-08-01
00883475953428MS Round-ST-CV22-03BNKP2024-08-01
00883475951370Pressure Adjustable Micro-Sucker 7S31-50572023-09-18
00883475651300IOL Hook37-00022023-09-18
00883475651324Capsulorrhexis Forceps37-00042023-09-18
00883475651331Micro Scissors(Acute tips)37-00052023-09-18
00883475651348Micro Scissors(Blunt tips)37-00062023-09-18
00883475651355Iris Forceps37-00072023-09-18
00883475651362Needle Holder37-00082023-09-18
00883475651379Wire Speculum37-00092023-09-18
00883475651386Wire Speculum with Blade37-00102023-09-18
00883475679038Micro Forceps CROSS MAX37-00112023-09-18
00883475679045Cilia Forceps CROSS MAX37-00122023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18
00190776411107MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411473MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411497MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411510MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02