HC Biologics

GUDID 10815634021317

OsteoPoint Graft Delivery Device

MICROMEDICS, INC.

Bone graft delivery kit
Primary Device ID10815634021317
NIH Device Record Key8000d6b8-b8fd-4391-8591-d3a9acb74676
Commercial Distribution StatusIn Commercial Distribution
Brand NameHC Biologics
Version Model NumberHC-OPM100
Company DUNS066839630
Company NameMICROMEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815634021310 [Primary]
GS110815634021317 [Package]
Contains: 00815634021310
Package: Inner Pack [5 Units]
In Commercial Distribution
GS120815634021314 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-24
Device Publish Date2021-08-16

Devices Manufactured by MICROMEDICS, INC.

10815634021768 - Fibrijet2024-06-26 Endoscopic Catheter Introducer
00815634020788 - Biomet Biologics2023-12-13 Biomet Biologics Regulator
10815634021089 - Nordson Medical2023-06-14 MALLEABLE APPLICATOR TIP, STERILE, 0.160in OD x 5.51in L
00815634021358 - Pramand2023-05-19 Air Assisted Sprayer
10815634021782 - FibriJet2023-03-29 FIBRIJET REGULATOR
30815634021472 - FibriJet2023-03-08 Case 250 (bulk) individually pouched AMS600 devices corresponding to pouch UDI-DI 00815634021471
30815634021519 - FibriJet2023-03-08 MAGELLAN SPRAY TIP, DUAL SPRAY, BULK STERILE, Case of 250, corresponding to individual pouched AMS700 UDI-DI of 00815634021518
10815634021065 - Nordson Medical2022-11-14 Gasless Applicator 40CM, OUS - Baxter

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.