FDA.reportPublic FDA data

n/a

Primary DI
00822409104178
Brand
n/a
Company
Ortho Development Corporation
Model
880-0003
Device description
Troch Nail Curved Awl
Published
2022-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409104178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409104178008224091041788224091041780822409104178

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822409130153N/A863-12062025-03-17
00822409130160N/A863-12072025-03-17
00822409130177N/A863-12082025-03-17
00822409130184N/A863-12092025-03-17
00822409130191N/A863-12102025-03-17
00822409130207N/A863-12112025-03-17
00822409130214N/A863-22062025-03-17
00822409130221N/A863-22072025-03-17
00822409130238N/A863-22082025-03-17
00822409130245N/A863-22092025-03-17
00822409130252N/A863-22102025-03-17
00822409130269N/A863-22112025-03-17
00822409082124N/A233-01382026-07-16
00822409082131N/A233-01392026-07-16
00822409082148N/A233-01402026-07-16
00822409082155N/A233-01412026-07-16
00822409082162N/A233-01422026-07-16
00822409082179N/A233-01432026-07-16
00822409082186N/A233-01442026-07-16
00822409082193N/A233-01452026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169524699Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-09-20
04054896000770AwlSilony Medical GmbHHWJ2026-09-18
04054896000787AwlSilony Medical GmbHHWJ2026-09-18
04054896002927AwlSilony Medical GmbHHWJ2026-09-18
04054896005553AwlSilony Medical GmbHHWJ2026-09-18
04054896005560AwlSilony Medical GmbHHWJ2026-09-18
04054896005577AwlSilony Medical GmbHHWJ2026-09-18
04054896014999AwlSilony Medical GmbHHWJ2026-09-18
04054896015002AwlSilony Medical GmbHHWJ2026-09-18
04054896021669AwlSilony Medical GmbHHWJ2026-09-18
04054896024288AwlSilony Medical GmbHHWJ2026-09-18
04054896024295AwlSilony Medical GmbHHWJ2026-09-18
04054896024301AwlSilony Medical GmbHHWJ2026-09-18
04054896024318AwlSilony Medical GmbHHWJ2026-09-18
04054896032818AwlSilony Medical GmbHHWJ2026-09-18
04054896052595AwlSilony Medical GmbHHWJ2026-09-18
04054896052601AwlSilony Medical GmbHHWJ2026-09-18
04054896056777AwlSilony Medical GmbHHWJ2026-09-18
04054896069289AwlSilony Medical GmbHHWJ2026-09-18
04054896079325AwlSilony Medical GmbHHWJ2026-09-18
04054896079332AwlSilony Medical GmbHHWJ2026-09-18
04054896079349AwlSilony Medical GmbHHWJ2026-09-18
04054896079356AwlSilony Medical GmbHHWJ2026-09-18
04054896079363AwlSilony Medical GmbHHWJ2026-09-18
04054896079370AwlSilony Medical GmbHHWJ2026-09-18
04054896079387AwlSilony Medical GmbHHWJ2026-09-18
04054896079394AwlSilony Medical GmbHHWJ2026-09-18
04054896079578AwlSilony Medical GmbHHWJ2026-09-18
04054896079585AwlSilony Medical GmbHHWJ2026-09-18
00199150076482Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03