FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD6787200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD67-8720
Catalog number
SD67-8720
Device description
7 1/2" Double-Ended Curette, oval ends, 2.2mm semi-sharp end at 45 Degree and 2.7mm sharp end at 90 Degree
Published
2026-10-28
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
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD6787200PrimaryHIBCC0

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
B382SD13517450Surgical DirectSD 1351745SD 13517452026-10-28
B382SD13518130Surgical DirectSD13518-13SD13518-132026-10-28
B382SD15908130Surgical DirectSD15908-13SD15908-132026-10-28
B382SD161310590Surgical DirectSD16131059SD161310592026-10-28
B382SD48310090Surgical DirectSD48-31009SD48-310092026-10-28
B382SD4865700Surgical DirectSD48-6570SD48-65702026-10-28
B382SD6200420Surgical DirectSD62-0042SD62-00422026-10-28
B382SD6200430Surgical DirectSD62-0043SD62-00432026-10-28
B382SD62372600Surgical DirectSD62-37260SD62-372602026-10-28
B382SD62372610Surgical DirectSD62-37261SD62-372612026-10-28
B382SD62372620Surgical DirectSD62-37262SD62-372622026-10-28
B382SD62372700Surgical DirectSD62-37270SD62-372702026-10-28
B382SD62372710Surgical DirectSD62-37271SD62-372712026-10-28
B382SD62372720Surgical DirectSD62-37272SD62-372722026-10-28
B382SD62373320Surgical DirectSD62-37332SD62-373322026-10-28
B382SD62373340Surgical DirectSD62-37334SD62-373342026-10-28
B382SD62373360Surgical DirectSD62-37336SD62-373362026-10-28
B382SD67371410Surgical DirectSD67-37141SD67-371412026-10-28
B382SD77505940Surgical DirectSD77505-94SD77505-942026-10-28
B382SD88820Surgical DirectSD8882SD88822026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435653MillenniumAvalign Technologies, Inc.GDG2026-10-21
B382SD4810110Surgical DirectSurgical Direct, Inc.GDG2026-10-20
B382SD922624103T0Surgical DirectSurgical Direct, Inc.GDG2026-10-20
00190776435431MillenniumAvalign Technologies, Inc.GDG2026-10-19
G141520422030Carnegie Surgical LLCCarnegie Surgical LLCGDG2026-09-30
G141520422040Carnegie Surgical LLCCarnegie Surgical LLCGDG2026-09-30
00724995267896Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-25
00190776432379MillenniumAvalign Technologies, Inc.GDG2026-09-24
00190776432423MillenniumAvalign Technologies, Inc.GDG2026-09-24
00724995267483Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267490Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267506Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267513Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267520Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267544Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267551Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267568Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267575Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267582Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267599Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267605Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267612Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267629Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00850088713954PRINCETONPrinceton Medical Group, Inc.GDG2026-09-22
00190776431099MillenniumAvalign Technologies, Inc.GDG2026-09-21
B033K941409" Nerve HookKapp Surgical Instrument Co.GDG2026-08-27
00810158215955PRINCETONPrinceton Medical Group, Inc.GDG2026-08-25
10850067560323MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560330MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560347MaxRetractSurgical Principals, IncGDG2026-08-25