FDA.reportPublic FDA data

OSSIO® Drill Pack

Primary DI
07290019361145
Brand
OSSIO® Drill Pack
Company
OSSIO LTD
Model
THN00484
Catalog number
THN00484
Device description
OSSIO® Drill Pack, 2.8mm For Staple 25x22 mm. Package contains: 1 Instrument Pack.
Published
2024-10-07
Public version status
Update
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019361145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019361145072900193611457290019361145

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
1-833-781-7373customer_service@ossio.io

Regulatory Flags#

DUNS number
600505107
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019361206OSSIOfiber® Interference ScrewOF1168023SOF1168023S2026-07-19
07290019361213OSSIOfiber® Interference ScrewOF1169023SOF1169023S2026-07-19
07290019361220OSSIOfiber® Interference ScrewOF1161023SOF1161023S2026-07-19
07290019361336OSSIO® InserterTHN00633THN006332026-07-19
07290019361343OSSIO® TapTHN00634THN006342026-07-19
07290019361350OSSIO® TapTHN00636THN006362026-07-19
07290019361367OSSIO® TapTHN00638THN006382026-07-19
07290019361374OSSIO® TapTHN00640THN006402026-07-19
07290019361381OSSIO® TapTHN00642THN006422026-07-19
07290019361190OSSIOfiber® Interference ScrewOF1167023SOF1167023S2026-05-13
07290017630946OSSIOfiber® Suture AnchorOF1035551SOF1035551S2023-09-14
07290017630601OSSIOfiber® Suture AnchorOF1034751SOF1034751S2022-06-06
07290017630618OSSIOfiber® Suture AnchorOF1034752SOF1034752S2022-06-06
07290017630625OSSIOfiber® Suture AnchorOF1034753SOF1034753S2022-06-06
07290017630632OSSIOfiber® Suture AnchorOF1034754SOF1034754S2022-06-06
07290017630649OSSIOfiber® Suture AnchorOF1034755SOF1034755S2022-06-06
07290017630571OSSIOfiber® Trimmable Fixation Nail System, CannulatedOF2054070S1OF2054070S2026-02-19
07290017630588OSSIOfiber® Threaded Trimmable Fixation NailOF1104570SOF1104570S2025-12-17
07290017630595OSSIOfiber® Threaded Trimmable Fixation Nail SystemOF2104530SOF2104530S2025-12-17
07290017630823OSSIOfiber® Compression ScrewOF1073534SOF1073534S2025-09-26

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