FDA.reportPublic FDA data

OsteoPoint

Primary DI
04260647240337
Brand
OsteoPoint
Company
Morpheus AG
Model
HCT-03-160
Device description
HC Biologics OsteoPoint Bone Removal System 3mm x 160mm
Published
2024-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260647240337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260647240337042606472403374260647240337

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315142027
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260647240320OsteoPointHCT-02-1602024-11-26
04260647240344OsteoPointHCT-04-1602024-11-26
04260647240351OsteoPointHCT-02-2002024-11-26
04260647240368OsteoPointHCT-03-2002024-11-26
04260647240375OsteoPointHCT-04-2002024-11-26
04260647240382OsteoPointHCT-BC-162024-11-26
04260647240207PUSHERSTO-0152023-11-16
04260647240238Rebellion REB-03-1602023-11-08
04260647240245RebellionREB-04-1602023-11-08
04260647240221RebellionREB-02-1602023-11-02
04260647240061PHANTOM MULTI-BITE KERRISON RONGEURKR-20022022-06-28
04260647240078PHANTOM MULTI-BITE KERRISON RONGEURKR-25022022-06-28
04260647240085PHANTOM MULTI-BITE KERRISON RONGEURKR-20032022-06-28
04260647240092PHANTOM MULTI-BITE KERRISON RONGEURKR-25032022-06-28
04260647240108PHANTOM MULTI-BITE KERRISON RONGEURKR-20042022-06-28
04260647240115PHANTOM MULTI-BITE KERRISON RONGEURKR-25042022-06-28
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEKR-01002022-06-28
04260647240214PUSHERKR-02002022-06-28
04260647240009RebellionREB-02-2002022-06-27
04260647240016RebellionREB-02-2502022-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400538MillenniumAvalign Technologies, Inc.HAE2026-07-19
00190776400316MillenniumAvalign Technologies, Inc.HAE2026-07-17
00190776400323MillenniumAvalign Technologies, Inc.HAE2026-07-17
00190776400354MillenniumAvalign Technologies, Inc.HAE2026-07-17
00810220800478Adler Instrument CompanyAdler, Inc.HAE2026-07-17
00190776397128MillenniumAvalign Technologies, Inc.HAE2026-07-16
00190776395520MillenniumAvalign Technologies, Inc.HAE2026-07-14
04255968300020VitalitecVitalitec International Medizintechnik GmbHHAE2026-06-23
07613327651676mild Device KitSTRYKER CORPORATIONHAE2024-11-22
B235MDK00020mild Device KitSTRYKER CORPORATIONHAE2024-06-19
G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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04046955074952AESCULAPAESCULAP, INC.HAE2019-04-30
10381780136552Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14
10381780136804Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14