FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9144781010
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD914478101
Catalog number
SD914478101
Device description
11" Cobb Spinal Gouge, Strong Curve, Round Knurled Handle
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B382SD9144781010PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9226391030Surgical DirectSD922639103SD9226391032023-02-22
B382SD9192442700Surgical DirectSD919244270SD9192442702022-12-01
B382SD48155416201210Surgical DirectSD4815541620-121SD4815541620-1212022-11-30
B382SD180190Surgical DirectSD18019SD180192020-04-29
B382SD180290Surgical DirectSD18029SD180292020-04-28
B382SD182490Surgical DirectSD18249SD182492020-04-29
B382SD182590Surgical DirectSD18259SD182592020-04-25
B382S25681060Surgical DirectS2568.106S2568.1062026-07-29
B382S340861270Surgical DirectS34086.127S34086.1272026-07-29
B382SD90557818E0Surgical DirectSD90557818ESD90557818E2026-07-29
B382SD90712216T0Surgical DirectSD90712216TSD90712216T2026-07-29
B382SD914709040Surgical DirectSD91470904SD914709042026-07-29
B382SD919327220Surgical DirectSD91932720SD919327202026-07-29
B382SD919327230Surgical DirectSD91932723SD919327232026-07-29
B382SD919523070Surgical DirectSD91952307SD919523072026-07-29
B382SD919523080Surgical DirectSD91952308SD919523082026-07-29
B382SD9196141000Surgical DirectSD919614100SD9196141002026-07-29
B382SD9196141010Surgical DirectSD919614101SD9196141012026-07-29
B382SD9200321000Surgical DirectSD920032100SD9200321002026-07-29
B382SD9200321060Surgical DirectSD920032106SD9200321062026-07-29

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
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
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
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