FDA.report

BethaLoc®

Primary DI
04048844259587
Brand
BethaLoc®
Company
implantcast GmbH
Model
87001056
Device description
broach
Published
2023-06-28
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
04048844259587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844259587040488442595874048844259587

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
04048844358617MUTARS®770300852026-03-24
04048844358716MUTARS®770301052026-03-24
04048844358792MUTARS®770301252026-03-24
04048844358839MUTARS®770301352026-03-24
04048844732103n/a800930002026-03-24
04048844738150implaFit®800820252026-03-24
04048844731977implaFit®800920002026-03-20
04048844731984implaFit®800920012026-03-20
04048844731991implaFit®800920022026-03-20
04048844732004implaFit®800920032026-03-20
04048844732028implaFit®800920062026-03-20
04048844732042implaFit®800920072026-03-20
04048844732059implaFit®800920082026-03-20
04048844732066implaFit®800920092026-03-20
04048844732080implaFit®800920112026-03-20
04048844732097implaFit®800920122026-03-20
04048844781101implaFit®800920052026-03-20
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17

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00810111222679BroachTreace Medical Concepts, Inc.HTQ2025-08-06
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