FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD62622080
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD62-62208
Catalog number
SD62-62208
Device description
"7"" Cottle Osteotomes, Graduated, 8mm"
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
B382SD62622080PrimaryHIBCC0

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
B382SD482012L0Surgical DirectSD48-2012LSD48-2012L2025-10-06
B382SD23170Surgical DirectSD2317SD23172026-10-15
B382SD25090Surgical DirectSD2509SD25092026-10-15
B382SD379410Surgical DirectSD37941SD379412026-10-15
B382SD4830070Surgical DirectSD48-3007SD48-30072026-10-15
B382SD4840320Surgical DirectSD48-4032SD48-40322026-10-15
B382SD48800050Surgical DirectSD48-80005SD48-800052026-10-15
B382SD491118030Surgical DirectSD49-111803SD49-1118032026-08-04
B382SD62371520Surgical DirectSD62-37152SD62-371522026-10-15
B382SD717510050Surgical DirectSD7175-1005SD7175-10052026-10-15
B382SD9025151020Surgical DirectSD902515102SD9025151022026-10-15
B382SD903223060Surgical DirectSD90322306SD903223062026-10-15
B382SD903454040Surgical DirectSD90345404SD903454042026-10-15
B382SD903454060Surgical DirectSD90345406SD903454062026-10-15
B382SD911434070Surgical DirectSD91143407SD911434072026-10-15
B382SD914174550Surgical DirectSD91417455SD914174552026-10-15
B382SD9141781090Surgical DirectSD914178109SD9141781092026-10-15
B382SD9141781620Surgical DirectSD914178162SD9141781622026-10-15
B382SD914603200Surgical DirectSD91460320SD914603202026-10-15
B382SD920761000Surgical DirectSD92076100SD920761002026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914455070Surgical DirectSurgical Direct, Inc.KDG2026-09-29
00810238290025PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713756PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713923PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713961PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713244PRINCETONPrinceton Medical Group, Inc.KDG2026-08-14
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
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
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