FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9200321020
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD920032102
Catalog number
SD920032102
Device description
Hartmann Speculum, 2.5 x 3.5 Oval
Published
2024-08-06
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
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
B382SD9200321020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. 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
B382S28531030Surgical DirectS2853.103S2853.1032026-06-08
B382S28531040Surgical DirectS2853.104S2853.1042026-06-08
B382S2853252T0Surgical DirectS2853.252TS2853.252T2026-06-08
B382S285401100Surgical DirectS2854.110S2854.1102026-06-08
B382SD902172106T0Surgical DirectSD902172106TSD902172106T2026-06-08
B382SD9023191000Surgical DirectSD902319100SD9023191002026-06-08
B382SD9027351020Surgical DirectSD902735102SD9027351022026-06-08
B382SD9028531080Surgical DirectSD902853108SD9028531082026-06-08
B382SD9028531260Surgical DirectSD902853126SD9028531262026-06-08
B382SD9028531290Surgical DirectSD902853129SD9028531292026-06-08
B382SD9028531720Surgical DirectSD902853172SD9028531722026-06-08
B382SD9028541100Surgical DirectSD902854110SD9028541102026-06-08
B382SD9028541170Surgical DirectSD902854117SD9028541172026-06-08
B382SD902861100T0Surgical DirectSD902861100TSD902861100T2026-06-08
B382SD902869400Surgical DirectSD90286940SD902869402026-06-08
B382SD902870110Surgical DirectSD90287011SD902870112026-06-08
B382SD902991101T0Surgical DirectSD902991101TSD902991101T2026-06-08
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453162762Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEGN2026-05-29
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
08961104625839MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625846MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625853MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625860MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625877MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625884MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625891MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625907MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625914MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625921MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625938MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625945MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625952MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625969MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625976MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625983MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625990MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626003MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626010MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626027MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626034MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626041MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626058MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626096MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626102MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626119MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626126MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626133MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22