FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD920730200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD92073020
Catalog number
SD92073020
Device description
5 1/4" House Mini Alligator Ear Forceps, Serrated, 0.6mm Jaw, 3.0 Long Jaws
Published
2022-12-05
Public version status
Update
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
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
B382SD920730200PrimaryHIBCC0

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
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
B382SD9141791400Surgical DirectSD914179140SD9141791402026-07-13
B382SD9142211000Surgical DirectSD914221100SD9142211002026-07-13
B382SD914264010Surgical DirectSD91426401SD914264012026-07-13
B382SD914341100Surgical DirectSD91434110SD914341102026-07-13
B382SD9143681000Surgical DirectSD914368100SD9143681002026-07-13
B382SD91705515T0Surgical DirectSD91705515TSD91705515T2026-07-13
B382SD91705525T0Surgical DirectSD91705525TSD91705525T2026-07-13
B382SD9176201020Surgical DirectSD917620102SD9176201022026-07-13
B382SD918006150Surgical DirectSD91800615SD918006152026-07-13
B382SD918006200Surgical DirectSD91800620SD918006202026-07-13
B382SD918174150Surgical DirectSD91817415SD918174152026-07-13
B382SD9183701030Surgical DirectSD918370103SD9183701032026-07-13
B382SD9183761030Surgical DirectSD918376103SD9183761032026-07-13
B382SD9184571000Surgical DirectSD918457100SD9184571002026-07-13
B382SD9184932000Surgical DirectSD918493200SD9184932002026-07-13
B382SD9153301000Surgical DirectSD915330100SD9153301002022-12-05
B382SD883110450Surgical DirectSD88311045SD883110452026-07-10
B382SD88324450Surgical DirectSD8832445SD88324452026-07-10
B382SD9032161000Surgical DirectSD903216100SD9032161002026-07-10
B382SD90390213SC0Surgical DirectSD90390213SCSD90390213SC2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258543Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258550Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258567Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.GEN2026-06-22
05060212051196Adson Non-Toothed Forceps 120mmDTR MEDICAL LIMITEDGEN2026-06-10
05060212051202Adson Toothed Forceps 120mmDTR MEDICAL LIMITEDGEN2026-06-10