FDA.reportPublic FDA data

Retractor Blade

Primary DI
04250337120414
Brand
Retractor Blade
Company
Joimax GmbH
Model
RB6583
Catalog number
RB6583
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
04250337120414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337120414042503371204144250337120414

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
04250337121961Biopsy Forceps, SpoonTHF2435412026-10-26
04250337121978Biopsy Forceps, Spoon, angledTHF2435352026-10-26
04250337106548Percusys® PlusJMPP0540PSJMPP0540PS2020-01-03
04250337106555Percusys® PlusJMPP0545PSJMPP0545PS2020-01-03
04250337106579Percusys® PlusJMPP0635PSJMPP0635PS2020-01-03
04250337106586Percusys® PlusJMPP0640PSJMPP0640PS2020-01-03
04250337106593Percusys® PlusJMPP0645PSJMPP0645PS2020-01-03
04250337106609Percusys® PlusJMPP0650PSJMPP0650PS2020-01-03
04250337106616Percusys® PlusJMPP0655PSJMPP0655PS2020-01-03
04250337106623Percusys® PlusJMPP0735PSJMPP0735PS2020-01-03
04250337106630Percusys® PlusJMPP0740PSJMPP0740PS2020-01-03
04250337106647Percusys® PlusJMPP0745PSJMPP0745PS2020-01-03
04250337106654Percusys® PlusJMPP0750PSJMPP0750PS2020-01-03
04250337106661Percusys® PlusJMPP0755PSJMPP0755PS2020-01-03
04250337106678Percusys® PlusJMPP0835PSJMPP0835PS2020-01-03
04250337106685Percusys® PlusJMPP0840PSJMPP0840PS2020-01-03
04250337106692Percusys® PlusJMPP0845PSJMPP0845PS2020-01-03
04250337107965Percusys® PlusJMPP0550PSJMPP0550PS2020-01-03
04250337117933Punching Adapter for Working TubeWTPA7695172026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redGRD1964402026-10-22

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Primary DI, Brand, Company table
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ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
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08056138586338MarkXM.D.L. S.R.L.GDF2025-02-28
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10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
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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
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10840199505811Needle HolderKOROS U.S.A., INC.GDF2022-04-01
10840199505828Needle HolderKOROS U.S.A., INC.GDF2022-04-01
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