FDA.reportPublic FDA data

Isto Disposable Awl 7.5/8.0 Anchor

Primary DI
B90839940758311
Brand
Isto Disposable Awl 7.5/8.0 Anchor
Company
Mainstream Medical Devices, LLC
Model
399-40-758-311
Catalog number
IFLX-DA-7580
Device description
Disposable Awl 7.5/8.0 Anchor
Published
2023-07-17
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
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B90839940758311PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, single-useA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is 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, typically made of metallic and/or synthetic material. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071513432
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B90829211908Main-AXS Needle-Retropsoas292-11-908292-11-9082025-04-30
B90830825080Main-Mallet308-25-080308-25-0802025-04-04
B90831225080Main-Mallet312-25-080312-25-0802025-04-04
B90831625080Main-Mallet316-25-080316-25-0802025-04-04
B90831635080Main-Mallet316-35-080316-35-0802025-04-04
B908350011000Main-Mallet-Spinal Simplicity316-35-91135-0011-0002025-04-04
B908350008000Main-AXS Needle-Spinal Simplicity292-11-92035-0008-0002024-12-03
B908350009000Main-AXS Needle-Spinal Simplicity299-08-90035-0009-0002024-12-03
B90831020150Sterile Drill Bit310-20-150310-20-1502024-08-09
B90831020150907Sterile Drill Bit - RMR310-20-150-90707.20.QDS2024-08-09
B90831025150Sterile Drill Bit310-25-150310-25-1502024-08-09
B90831027150Sterile Drill Bit310-27-150310-27-1502024-08-09
B90831027150907Sterile Drill Bit - RMR310-27-150-90707.27.QDS2024-08-09
B90831032150Sterile Drill Bit310-32-150310-32-1502024-08-09
B90831032150907Sterile Drill Bit - RMR310-32-150-90707.32.QDS2024-08-09
B9081600051Main-Knife RIGID 21mm, Alphatec451-25-9011600-052024-03-02
B9081600060Main-Knife - Alphatec471-25-9011600-062024-03-02
B90847125901Main-Knife - Alphatec471-25-9011600-062024-02-21
B90845125901Main-Knife RIGID 21mm, Alphatec451-25-9011600-052023-07-12
B90847125193Main-Knife - Alphatec471-25-193471-25-1932024-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169524699Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-09-20
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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