FDA.reportPublic FDA data

Medicon

Primary DI
04046826034801
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
26.10.12
Catalog number
26.10.12
Device description
Miller bone file d/e 18cm
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HTPFile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826034801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826034801040468260348014046826034801

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315492330
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
04046826047443Medicon44.90.7244.90.722026-07-31
04046826380830Medicon Tray906.90.57906.90.572026-07-30
04046826380939Medicon Tray906.90.76906.90.762026-07-30
04046826413187Medicon Tray906.92.05906.92.052026-07-30
04046826413194Medicon Tray906.92.06906.92.062026-07-30
04046826413200Medicon Tray906.92.08906.92.082026-07-30
04046826438180Medicon Tray906.92.18906.92.182026-07-30
04046826495800Medicon Tray906.91.32906.91.322026-07-30
04046826495954Medicon Tray906.91.87906.91.872026-07-30
04046826486228Medicon68.85.23A68.85.23A2026-07-29
04046826531478Medicon68.85.21A68.85.21A2026-07-29
04046826531485Medicon68.85.22A68.85.22A2026-07-29
04046826561741Medicon68.93.04A68.93.04A2026-07-29
04046826531454Medicon68.85.19A68.85.19A2026-07-28
04046826110833Medicon66.27.5366.27.532026-07-21
04046826346812Medicon68.86.89A68.86.89A2026-06-25
04046826416676Medicon68.87.28A68.87.28A2026-06-25
04046826542337Medicon68.86.4868.86.482026-06-25
04046826543655Medicon68.86.4968.86.492026-06-25
04046826552473Medicon68.93.4168.93.412026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD1832521590Surgical DirectSurgical Direct, Inc.HTP2026-07-31
B382SD1836S21590Surgical DirectSurgical Direct, Inc.HTP2026-07-31
B382SD1856S90Surgical DirectSurgical Direct, Inc.HTP2026-07-31
00840286860420Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HTP2026-07-10
00840286860413Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HTP2026-07-09
008401944974973P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HTP2026-06-10
10810128463574Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
10810128463581Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
06974940306642endophixSuzhou Endophix Co., Ltd.HTP2025-12-12
10818674026618Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
10818674026625Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101117INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101155INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844126998INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
00840286841955Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853965Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853972Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286841009TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-21
00840286855990TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856003TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856010TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856027TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856034TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840124518742FuzeFix MiniFUSION ORTHOPEDICS, LLCHTP2025-05-13
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-09
04047844058442INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-05
04047844058558RABEASIGNUS Medizintechnik GmbHHTP2025-03-12