FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD914603200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91460320
Catalog number
SD91460320
Device description
7 7/8" Daubenspeck Bone Curette, 0000, Angled, Sharp, Rigid, 2.80mm Jaw
Published
2026-10-15
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
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD914603200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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
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
B382SD920761000Surgical DirectSD92076100SD920761002026-10-15
B382SD1802S90Surgical DirectSD1802S9SD1802S92026-10-13
B382SD18146S90Surgical DirectSD18146S9SD18146S92026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267933Snowden-PencerSTERIS Deutschland GmbHEMK2026-10-15
B382SD920761000Surgical DirectSurgical Direct, Inc.EMK2026-10-15
B382SD914636200Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636210Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636230Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636240Surgical DirectSurgical Direct, Inc.EMK2026-10-09
G8791021780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102178H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
B382SD9213571010Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD9213571070Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD921480060Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD9238971060Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD934444090Surgical DirectSurgical Direct, Inc.EMK2026-08-07