FDA.reportPublic FDA data

APTUS

Primary DI
07630894820526
Brand
APTUS
Company
Medartis AG
Model
A-5045.47/2S
Catalog number
A-5045.47/2S
Device description
1.6 K-Wire, 90mm, Olive 40mm
Published
2025-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
07630037864585PrimaryGS10
07630894820526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037864585076300378645857630037864585
07630894820526076308948205267630894820526

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480054895
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894829819APTUSA-5788.12/1SA-5788.12/1S2026-06-01
07630894829826APTUSA-5788.14/1SA-5788.14/1S2026-06-01
07630894829833APTUSA-5788.16/1SA-5788.16/1S2026-06-01
07630894829840APTUSA-5788.18/1SA-5788.18/1S2026-06-01
07630894829857APTUSA-5788.20/1SA-5788.20/1S2026-06-01
07630894829864APTUSA-5788.22/1SA-5788.22/1S2026-06-01
07630894829871APTUSA-5788.24/1SA-5788.24/1S2026-06-01
07630894829888APTUSA-5788.26/1SA-5788.26/1S2026-06-01
07630894829895APTUSA-5788.28/1SA-5788.28/1S2026-06-01
07630894829901APTUSA-5788.30/1SA-5788.30/1S2026-06-01
07630894829918APTUSA-5788.32/1SA-5788.32/1S2026-06-01
07630894829925APTUSA-5788.34/1SA-5788.34/1S2026-06-01
07630894829932APTUSA-5788.36/1SA-5788.36/1S2026-06-01
07630894829949APTUSA-5788.38/1SA-5788.38/1S2026-06-01
07630894829956APTUSA-5788.40/1SA-5788.40/1S2026-06-01
07630894829963APTUSA-5788.42/1SA-5788.42/1S2026-06-01
07630894829970APTUSA-5788.44/1SA-5788.44/1S2026-06-01
07630894829987APTUSA-5788.46/1SA-5788.46/1S2026-06-01
07630894829994APTUSA-5788.48/1SA-5788.48/1S2026-06-01
07630894830006APTUSA-5788.50/1SA-5788.50/1S2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10840199534132Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534149Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534156Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534163Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534170Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534187Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534194Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534231Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534248Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534255Needle HolderKOROS U.S.A., INC.GDF2022-08-01