FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD920344100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD92034410
Catalog number
SD92034410
Device description
"7 1/2"" Sickle Knife, Blunt Tip, Straight"
Published
2024-11-26
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD920344100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear excavatorA hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of the middle ear and the sinus timpani. It is made of high-grade stainless steel and typically designed as a double-ended instrument having a central handle with small and sharp spoon-, scoop-, or spatula-shaped blades that have cutting/gouging edges. 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
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14
B382SD484600Surgical DirectSD48460SD484602026-08-07
B382SD484620Surgical DirectSD48462SD484622026-08-07
B382SD902508070Surgical DirectSD90250807SD902508072026-08-07
B382SD902509010Surgical DirectSD90250901SD902509012026-08-07
B382SD9025181000Surgical DirectSD902518100SD9025181002026-08-07
B382SD9028531640Surgical DirectSD902853164SD9028531642026-08-07
B382SD9032161050Surgical DirectSD903216105SD9032161052026-08-07
B382SD9032191040Surgical DirectSD903219104SD9032191042026-08-07
B382SD9032191050Surgical DirectSD903219105SD9032191052026-08-07
B382SD9034951000Surgical DirectSD903495100SD9034951002026-08-07
B382SD9034951010Surgical DirectSD903495101SD9034951012026-08-07
B382SD9037751020Surgical DirectSD903775102SD9037751022026-08-07
B382SD903797050Surgical DirectSD90379705SD903797052026-08-07
B382SD9213571010Surgical DirectSD921483109SD9214831092026-08-07
B382SD9213571070Surgical DirectSD921357107SD9213571072026-08-07
B382SD9213711000Surgical DirectSD921396115SD9213961152026-08-07
B382SD9213711010Surgical DirectSD921371101SD9213711012026-08-07
B382SD921377200Surgical DirectSD92137720SD921377202026-08-07
B382SD921381030Surgical DirectSD92138103SD921381032026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417727MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776426767MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776417109MillenniumAvalign Technologies, Inc.GEN2026-08-18
00198506094002ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00198506094057ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00190776425838MillenniumAvalign Technologies, Inc.GEN2026-08-17
G453333630140PEAK MEDICALPeak Medical Distribution Inc.GEN2026-08-14
00190776423544MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776423735MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776424404MillenniumAvalign Technologies, Inc.GEN2026-08-07
B382SD9238971100Surgical DirectSurgical Direct, Inc.GEN2026-08-07
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422721MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422769MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422790MillenniumAvalign Technologies, Inc.GEN2026-08-03
B382SD4829170Surgical DirectSurgical Direct, Inc.GEN2026-08-03
00190776422141MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422226MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422233MillenniumAvalign Technologies, Inc.GEN2026-07-31
B382SD1426525010Surgical DirectSurgical Direct, Inc.GEN2026-07-31
B382SD1426525020Surgical DirectSurgical Direct, Inc.GEN2026-07-31
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30