FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9162110970
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD916211097
Catalog number
SD916211097
Device description
"12"" Cystic Duct Scoop"
Published
2026-03-02
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
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9162110970PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. 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
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B382SD48800210Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382SD48800220Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382S344441010Surgical DirectSurgical Direct, Inc.EMK2026-07-31
B382SD914631720Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631770Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631780Surgical DirectSurgical Direct, Inc.EMK2026-07-27