FDA.reportPublic FDA data

REDFIELD CORPORATION

Primary DI
00888937013504
Brand
REDFIELD CORPORATION
Company
Coopersurgical, Inc.
Model
IRC-HS1
Device description
REDFIELD IRC 2100™
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974168000COOPERSURGICAL INFRARED COAGULATORHogan & Hartson1998-01-23KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937013504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937013504008889370135048889370135040888937013504

GMDN Terms#

Term, Definition table
TermDefinition
Infrared tissue coagulation systemAn assembly of electrically-powered devices designed to produce infrared (IR) light used to heat blood vessels and soft tissues for haemostasis and/or tissue removal. It typically consists of a control unit, a handpiece, light guides, and contact tips. It may be used to stop bleeding, to remove superficial lesions (e.g., haemorrhoids, benign vaginal lesions, warts, tattoos), for tonsillectomy/adenotomy blood staunching, and to treat parenchymal or dental bleeding. The use of IR light helps to avoid/mimimize some adverse outcomes associated with the application of direct electrical current (e.g., electrode-tissue adhesions).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901663NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901687NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901700NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901717NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664903520NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910566NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910597NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911976NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912096NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912102NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912119NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664919118NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934036NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934067NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934074NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934098NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17