FDA.report

EcoFit® broach for short stem 133°

Primary DI
04048844321710
Brand
EcoFit® broach for short stem 133°
Company
implantcast GmbH
Model
70404100
Published
2022-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTQBroach

Product Code Classifications

CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048844321710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844321710040488443217104048844321710

GMDN Terms

TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
324369826
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048844693367implaFit®800900012026-03-26
04048844693411implaFit®800900062026-03-26
04048844693442implaFit®800900092026-03-26
04048844693510implaFit®800910032026-03-26
04048844693565implaFit®800910082026-03-26
04048844693596implaFit®800910112026-03-26
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17
04048844693398implaFit®800900042026-03-17
04048844693404implaFit®800900052026-03-17
04048844693428implaFit®800900072026-03-17
04048844693435implaFit®800900082026-03-17
04048844693459implaFit®800900102026-03-17
04048844693466implaFit®800900112026-03-17
04048844693473implaFit®800900122026-03-17
04048844693497implaFit®800910012026-03-17
04048844693503implaFit®800910022026-03-17
04048844693527implaFit®800910042026-03-17
04048844693534implaFit®800910052026-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889797112307Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00889797112314Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00810111222679BroachTreace Medical Concepts, Inc.HTQ2025-08-06
00822409130962N/AOrtho Development CorporationHTQ2025-06-25
00822409130979N/AOrtho Development CorporationHTQ2025-06-25
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
00840286841740Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841757Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841764Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841771Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841788Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841795Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841801Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841818Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841825Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841832Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841849Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841856Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841863Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841870Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841887Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841894Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286840491TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840507TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840514TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840521TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840538TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840545TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840552Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840569TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21