FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD62622070
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD62-62207
Catalog number
SD62-62207
Device description
"7"" Cottle Osteotomes, Graduated, 7mm"
Published
2025-10-14
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
B382SD62622070PrimaryHIBCC0

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
B382SD484600Surgical DirectSD48460SD484602026-08-07
B382SD484620Surgical DirectSD48462SD484622026-08-07
B382SD902508070Surgical DirectSD90250807SD902508072026-08-07
B382SD902509010Surgical DirectSD90250901SD902509012026-08-07
B382SD9025181000Surgical DirectSD902518100SD9025181002026-08-07
B382SD9028531640Surgical DirectSD902853164SD9028531642026-08-07
B382SD9032161050Surgical DirectSD903216105SD9032161052026-08-07
B382SD9032191040Surgical DirectSD903219104SD9032191042026-08-07
B382SD9032191050Surgical DirectSD903219105SD9032191052026-08-07
B382SD9034951000Surgical DirectSD903495100SD9034951002026-08-07
B382SD9034951010Surgical DirectSD903495101SD9034951012026-08-07
B382SD9037751020Surgical DirectSD903775102SD9037751022026-08-07
B382SD903797050Surgical DirectSD90379705SD903797052026-08-07
B382SD9213571010Surgical DirectSD921483109SD9214831092026-08-07
B382SD9213571070Surgical DirectSD921357107SD9213571072026-08-07
B382SD9213711000Surgical DirectSD921396115SD9213961152026-08-07
B382SD9213711010Surgical DirectSD921371101SD9213711012026-08-07
B382SD921377200Surgical DirectSD92137720SD921377202026-08-07
B382SD921381030Surgical DirectSD92138103SD921381032026-08-07
B382SD9213821020Surgical DirectSD921382102SD9213821022026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093821ELMED INCORPORATEDELMED INCORPORATEDKDG2026-07-29
04059453095022Hermann Medizintechnik GmbHHermann Medizintechnik GmbHKDG2026-07-27
B382SD914455280Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD914457090Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD914457260Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD914458100Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD9144781000Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD9144781010Surgical DirectSurgical Direct, Inc.KDG2026-07-27
00850088713190PRINCETONPrinceton Medical Group, Inc.KDG2026-07-23
04059453127891Hermann Medizintechnik GmbHHermann Medizintechnik GmbHKDG2026-07-16
B382SD918006150Surgical DirectSurgical Direct, Inc.KDG2026-07-13
B382SD918006200Surgical DirectSurgical Direct, Inc.KDG2026-07-13
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
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical 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
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