FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S7941000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S794.100
Catalog number
S794.100
Device description
4 3/8" Castroviejo Corneal Scissors, Curved, Blunt Tips, Three-Hole Handle
Published
2026-07-31
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
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382S7941000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use 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
B382SD9030741020Surgical DirectSD903074102SD9030741022026-10-08
B382SD907019950Surgical DirectSD90701995SD907019952026-10-08
B382SD9071922050Surgical DirectSD907192205SD9071922052026-10-08
B382SD911160330Surgical DirectSD91116033SD911160332026-10-08
B382SD915039160Surgical DirectSD91503916SD915039162026-10-08
B382SD918660100Surgical DirectSD91866010SD918660102026-10-08
B382SD922616030Surgical DirectSD92261603SD922616032022-12-01
B382SD6713210Surgical DirectSD67-1321SD67-13212026-10-07
B382SD6713290Surgical DirectSD67-1329SD67-13292026-10-07
B382SD9013551000Surgical DirectSD901355100SD9013551002026-10-07
B382SD9013551010Surgical DirectSD901355101SD9013551012026-10-07
B382SD134188100Surgical DirectSD13418-810SD13418-8102026-10-06
B382SD13798330Surgical DirectSD13798-33SD13798-332026-10-06
B382SD6520450Surgical DirectSD65-2045SD65-20452026-10-06
B382SD6562120Surgical DirectSD65-6212SD65-62122026-10-06
B382SD902866230Surgical DirectSD90286623SD902866232026-10-06
B382SD905582180Surgical DirectSD90558218SD905582182026-10-06
B382SD9056791090Surgical DirectSD905679109SD9056791092026-10-06
B382SD9056791170Surgical DirectSD905679117SD9056791172026-10-06
B382SD915598230Surgical DirectSD91559823SD915598232026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9030741020Surgical DirectSurgical Direct, Inc.EGN2026-10-08
G879103050TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103052SC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103062TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103065TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030900DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030920DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030930DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103107TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103113TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103116TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103118TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031230DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879GTC130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
B382SD903260120Surgical DirectSurgical Direct, Inc.EGN2026-09-29