FDA.reportPublic FDA data

guiding sleeve

Primary DI
04250337109259
Brand
guiding sleeve
Company
Joimax GmbH
Model
GTC151510
Catalog number
GTC151510
Device description
Guiding Tube, conical, violet
Published
2022-12-30
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337109259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337109259042503371092594250337109259

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, reusableA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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
04250337117384video lensCSFHD01COVZCSFHD01COVZ2022-12-30
04260744830561Fibre optic cableCSLC0348CSLC03482022-12-30
04260744831865Fibre optic cableCSLC0252CSLC02522022-12-30
04250337119876Sterilisation trayJSBDSST4680JSBDSST46802022-12-30
04250337110040intENTS®TNC582810GTNC582810G2022-12-30
04250337110057MultiZYTE®TNC582814GTNC582814G2022-12-30
04250337110064iLESSYS®TNC582820RTNC582820R2022-12-30
04250337113041TESSYS®TNC582820TNC5828202022-12-30
04250337117537tubTNC5828100TNC58281002022-12-30
04250337117544tubTNC5828135TNC58281352022-12-30
04250337117551tubTNC5828150TNC58281502022-12-30
04250337117568tubTNC5828200TNC58282002022-12-30
04250337117575iLESSYS®TNC5828CLTNC5828CL2022-12-30
04250337117582iLESSYS®TNC5828ILTNC5828IL2022-12-30
04250337117599iLESSYS®TNC5828MLTNC5828ML2022-12-30
04250337117605iLESSYS®TNC5828NLTNC5828NL2022-12-30
04250337117612iLESSYS®TNC5828TLTNC5828TL2022-12-30
04250337117827iLESSYS®TNC5828ALTNC5828AL2022-12-30
04250337120759deflectorJSBS311509JSBS3115092025-07-25
04250337120766deflectorJSBS311512JSBS3115122025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436040Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436057Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436064Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436071Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436088Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436095Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436101Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17