FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD921381020
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD92138102
Catalog number
SD92138102
Device description
"7 1/2"" Miller-Colburn Rasp, Cross Cut End, #2"
Published
2025-08-11
Public version status
New
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
B382SD921381020PrimaryHIBCC0

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
B382SD484610Surgical DirectSD48461SD484612026-07-09
B382SD484630Surgical DirectSD48463SD484632026-07-09
B382SD484640Surgical DirectSD48464SD484642026-07-09
B382SD484650Surgical DirectSD48465SD484652026-07-09
B382SD484660Surgical DirectSD48466SD484662026-07-09
B382SD484670Surgical DirectSD48467SD484672026-07-09
B382SD484680Surgical DirectSD48468SD484682026-07-09
B382SD484690Surgical DirectSD48469SD484692026-07-09
B382SD484700Surgical DirectSD48470SD484702026-07-09
B382SD484710Surgical DirectSD48471SD484712026-07-09
B382SD484720Surgical DirectSD48472SD484722026-07-09
B382SD49400B0Surgical DirectSD49400BSD49400B2026-07-09
B382SD49401B0Surgical DirectSD49401BSD49401B2026-07-09
B382SD49402B0Surgical DirectSD49402BSD49402B2026-07-09
B382SD49403B0Surgical DirectSD49403BSD49403B2026-07-09
B382SD49404B0Surgical DirectSD49404BSD49404B2026-07-09
B382SD49405B0Surgical DirectSD49405BSD49405B2026-07-09
B382SD49406B0Surgical DirectSD49406BSD49406B2026-07-09
B382SD49407B0Surgical DirectSD49407BSD49407B2026-07-09
B382SD49408B0Surgical DirectSD49408BSD49408B2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD921381110Surgical DirectSurgical Direct, Inc.KDG2026-02-12
B382SD9144841130Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841180Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9144841190Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD921613120Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201100Surgical DirectSurgical Direct, Inc.KDG2025-11-05
B382SD9233201110Surgical DirectSurgical Direct, Inc.KDG2025-11-05
00198506086465ELMED INCORPORATEDELMED INCORPORATEDKDG2025-11-05
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622070Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622080Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622090Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622100Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622120Surgical DirectSurgical Direct, Inc.KDG2025-10-14
00810158217577PRINCETONPrinceton Medical Group, Inc.KDG2025-10-08
00810158216938PRINCETONPrinceton Medical Group, Inc.KDG2025-09-10
10840199528834Comfort Plus ChiselKOROS U.S.A., INC.KDG2025-01-31
10888277381339MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10888277392304MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10840199511423ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199511430ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199527394OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527400OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527417OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527424OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527431OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527448OsteotomeKOROS U.S.A., INC.KDG2024-12-31
10840199527455OsteotomeKOROS U.S.A., INC.KDG2024-12-31