FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9144601030
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD914460103
Catalog number
SD914460103
Device description
8 inch Stille Chisel, 11/16 inch
Published
2022-11-30
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
KDGCHISEL (OSTEOTOME)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9144601030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914459320Surgical DirectSurgical Direct, Inc.KDG2026-02-25
B382SD914031000Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914031010Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914456290Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663010Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663020Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663030Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663040Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD914591000Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD921648100Surgical DirectSurgical Direct, Inc.KDG2026-02-09
00810158218635PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218734PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218499PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
00810158218536PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
B382SD48820520Surgical DirectSurgical Direct, Inc.KDG2025-12-02
00810158218086PRINCETONPrinceton Medical Group, Inc.KDG2025-11-24
00810158217393PRINCETONPrinceton Medical Group, Inc.KDG2025-09-29
B382SD9219563010Surgical DirectSurgical Direct, Inc.KDG2025-09-22
B382SD936682100Surgical DirectSurgical Direct, Inc.KDG2025-09-18
B382SD9146891000Surgical DirectSurgical Direct, Inc.KDG2025-09-12
00810158216471PRINCETONPrinceton Medical Group, Inc.KDG2025-08-21
00810158215894PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216044PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216051PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216068PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216075PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216082PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
B382SD921381020Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646030Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646040Surgical DirectSurgical Direct, Inc.KDG2025-08-11