FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD915580100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91558010
Catalog number
SD91558010
Device description
10" Meigs Uterine Curette, Serrated 5mm x 9mm Cup
Published
2026-07-28
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
PCFSampler, Endocervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCFSampler, EndocervicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD915580100PrimaryHIBCC0

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(386) 738-1202info@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
B382SD309390Surgical DirectSD30939SD309392026-10-20
B382SD4810110Surgical DirectSD48-1011SD48-10112026-10-20
B382SD62362020Surgical DirectSD62362-02SD62362-022026-10-20
B382SD907310070Surgical DirectSD90731007SD907310072026-10-20
B382SD915070010Surgical DirectSD91507001SD915070012026-10-20
B382SD915070020Surgical DirectSD91507002SD915070022026-10-20
B382SD915070030Surgical DirectSD91507003SD915070032026-10-20
B382SD915758300Surgical DirectSD91575830SD915758302026-10-20
B382SD917665100Surgical DirectSD91766510SD917665102026-10-20
B382SD917665110Surgical DirectSD91766511SD917665112026-10-20
B382SD917665120Surgical DirectSD91766512SD917665122026-10-20
B382SD917665700Surgical DirectSD91766570SD917665702026-10-20
B382SD917665920Surgical DirectSD91766592SD917665922026-10-20
B382SD917665930Surgical DirectSD91766593SD917665932026-10-20
B382SD9210921080Surgical DirectSD921092108SD9210921082026-10-20
B382SD922624103T0Surgical DirectSD922624103TSD922624103T2026-10-20
B382SD9228132200Surgical DirectSD922813220SD9228132202026-10-20
B382SD9228132210Surgical DirectSD922813221SD9228132212026-10-20
B382SD9228132220Surgical DirectSD922813222SD9228132222026-10-20
B382SD9228132300Surgical DirectSD922813230SD9228132302026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9150991000Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD91553010100Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD91553010110Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301040Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301050Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301060Surgical DirectSurgical Direct, Inc.PCF2026-07-28
B382SD9155301080Surgical DirectSurgical Direct, Inc.PCF2026-07-28
20859500005053FemCervFEMASYS INC.PCF2022-09-21
20859500005060FemCervFEMASYS INC.PCF2022-09-21
30859500005050FemCervFEMASYS INC.PCF2022-09-21
30859500005067FemCervFEMASYS INC.PCF2022-09-21
10859500005056FemCervFEMASYS INC.PCF2022-09-21
10859500005063FemCervFEMASYS INC.PCF2022-09-21
00859500005059FemCervFEMASYS INC.PCF2022-09-21
00859500005066FemCervFEMASYS INC.PCF2022-09-21
00888937003253Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20
20888937003257Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20