FDA.reportPublic FDA data

Rumex

Primary DI
00840159908532
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
1-030T
Catalog number
1-030T
Device description
Chuck Handle, Length 100 mm, Titanium
Published
2020-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159908532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159908532008401599085328401599085320840159908532

GMDN Terms#

Term, Definition table
TermDefinition
Razor blade breaker/holderA surgical instrument specially designed to be used to break, breakable razor blades into shards of extremely sharp segments. Once this is done the instrument can then be used as a safety holder for the segment of broken razor blade, acting as a handle, whilst the surgeon uses it like a scalpel to cut tissue. When the operation is completed the segment of blade is disposed of. Some physicians prefer this method which guarantees the sharpness of the cutting edge. This device is made of high quality stainless-steel alloy and is designed like a short-nosed plier with a locking device to lock the blade segment securely in place. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
041546137
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840159901397Rumex4-072T4-072T2020-07-27
00840159901403Rumex4-0741S4-0741S2020-07-27
00840159901410Rumex4-0741T4-0741T2020-07-27
00840159901427Rumex4-090T4-090T2020-07-27
00840159901434Rumex4-091S4-091S2020-07-27
00840159901441Rumex4-092T4-092T2020-07-27
00840159901458Rumex4-111T4-111T2020-07-27
00840159901465Rumex4-113T4-113T2020-07-27
00840159901472Rumex4-121S4-121S2020-07-27
00840159901489Rumex4-122S4-122S2020-07-27
00840159901496Rumex4-123S4-123S2020-07-27
00840159901502Rumex4-136S4-136S2020-07-27
00840159901519Rumex4-140T4-140T2020-07-27
00840159901526Rumex4-171S4-171S2020-07-27
00840159901533Rumex4-175T4-175T2020-07-27
00840159901540Rumex4-176T4-176T2020-07-27
00840159901557Rumex4-177S4-177S2020-07-27
00840159901564Rumex4-185S4-185S2020-07-27
00840159901571Rumex4-185T4-185T2020-07-27
00840159901588Rumex4-1906T4-1906T2020-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776418038MillenniumAvalign Technologies, Inc.GDZ2026-03-23
16937372521523comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521530comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521547comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521554comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521561comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
16937372521578comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDZ2026-03-19
B382SD914010350Surgical DirectSurgical Direct, Inc.GDZ2026-02-25
B382SD4811280Surgical DirectSurgical Direct, Inc.GDZ2026-02-16
00190776416157MillenniumAvalign Technologies, Inc.GDZ2026-02-06
00840124525320FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
00840124525337FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-02-03
09348811000019INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000095INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000132INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000149INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000170INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000187INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000194INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000200INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000217INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811000224INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014146INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014856INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811014863INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
09348811151452INKAThe Trustee for KAISER FAMILY TRUSTGDZ2026-01-30
00840124525245FuzeFix MiniFUSION ORTHOPEDICS, LLCGDZ2026-01-22
00841013120480Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-06
00841013124327American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02
00841013124334American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.GDZ2026-01-02