FDA.reportPublic FDA data

T-Han Delivery System

Primary DI
00850080243145
Brand
T-Han Delivery System
Company
BONE SOLUTIONS, INC.
Model
4.2 x 180mm
Catalog number
RM44-053
Device description
The Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Published
2026-02-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850080243145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080243145008500802431458500802431450850080243145

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic coaxial injection applicatorA tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8178098850customerservice@bonesolutions.net

Regulatory Flags#

DUNS number
003506272
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080243176OSTEOROD Delivery SystemOSTEORODRM44-0702026-10-12
00850080243022Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-STR2026-06-18
00850080243039Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-STR2026-06-18
00850080243046Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-STR2026-06-18
00850080243053Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-BSI2026-06-18
00850080243060Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-BSI2026-06-18
00850080243077Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-BSI2026-06-18
00850080243084Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2026-06-18
00850080243091Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2026-06-18
00850080243107Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2026-06-18
00850080243114Mg OSTEOINJECT® bone graft substitute5cc44-050-00-INJ2026-06-18
00850080243121Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2026-06-18
B4474410000INJ0Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2024-05-20
B4474405000REV0Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2022-02-02
B4474410000REV0Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2022-02-02
B4474415000REV0Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2022-02-02
B4474405000INJ0Mg OSTEOINJECT® bone graft substitute5cc44-050-00-INJ2022-01-11
B4477120050Opus Mg Set BVF5cc7120052021-09-27
B4477120100Opus Mg Set BVF10cc7120102021-09-27
B4477120150Opus Mg Set BVF15cc7120152021-09-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810130456987Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
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