FDA.reportPublic FDA data

Retractor Blade

Primary DI
04250337120421
Brand
Retractor Blade
Company
Joimax GmbH
Model
RB9583
Catalog number
RB9583
Device description
Retractor Blade with handle, curved Lip
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337120421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337120421042503371204214250337120421

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held endoscopic retractor, reusableA hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337118022Intracs®JINTST15JINTST152022-12-30
04250337118039Intracs®JINTST18JINTST182022-12-30
04250337118046Intracs®JINTST23JINTST232022-12-30
04250337116530Joimax® Intracs® EM System Integrated Navigation Tracking & Control SystemJINT01S2021-11-12
04250337116547Joimax® Intracs® EM Panel PCJINTPC11052021-11-12
04250337116554Joimax® Intracs® EM Control UnitJINTCU11152021-11-12
04250337116561Joimax® Intracs® EM Field GeneratorJINTFG11252021-11-12
04250337116585Joimax® Intracs® EM Patient TrackerJINTPT22352021-11-12
04250337116592Joimax® Intracs® EM Sensor ClipJINTSC22052021-11-12
04250337116608Joimax® Intracs® EM Sensor Wire 150JINTSW22152021-11-12
04250337116615Joimax® Intracs® EM Sensor Wire 180JINTSW22182021-11-12
04250337116622Joimax® Intracs® EM Sensor Wire 230JINTSW22232021-11-12
04250337116646Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clampJINTMA11352021-11-12
04250337117667Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clampJINTMAP11362021-11-12
04250337117988Wire cutterJINTWC2021-11-12
04250337117995Joimax® Intracs® EM Y-AdapterJINTYA352021-11-12
04250337118008Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mmJINTDG1828602021-11-12
04250337118015K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mmJKW15152021-11-12
04250337118213Joimax® Intracs® EM Patient Mapper - APJINTPM2245-AP2021-11-12
04250337118220Joimax® Intracs® EM Patient Mapper - LATJINTPM2245-LAT2021-11-12

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Primary DI, Brand, Company table
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04048223069738TunnEler 235Pajunk GmbH MedizintechnologieGDF2026-06-10
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
08056138586338MarkXM.D.L. S.R.L.GDF2025-02-28
08057276004715MarkXM.D.L. S.R.L.GDF2025-02-28
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199505767Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505774Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505798Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505804Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505811Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505828Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505835Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505842Needle HolderKOROS U.S.A., INC.GDF2022-04-01