FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD4838920
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD48-3892
Catalog number
SD48-3892
Device description
10 3/8" Meniscus Probe, 1.8mm Tip
Published
2026-08-03
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD4838920PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
B382SD482012L0Surgical DirectSD48-2012LSD48-2012L2025-10-06
B382SD23170Surgical DirectSD2317SD23172026-10-15
B382SD25090Surgical DirectSD2509SD25092026-10-15
B382SD379410Surgical DirectSD37941SD379412026-10-15
B382SD4830070Surgical DirectSD48-3007SD48-30072026-10-15
B382SD4840320Surgical DirectSD48-4032SD48-40322026-10-15
B382SD48800050Surgical DirectSD48-80005SD48-800052026-10-15
B382SD491118030Surgical DirectSD49-111803SD49-1118032026-08-04
B382SD62371520Surgical DirectSD62-37152SD62-371522026-10-15
B382SD717510050Surgical DirectSD7175-1005SD7175-10052026-10-15
B382SD9025151020Surgical DirectSD902515102SD9025151022026-10-15
B382SD903223060Surgical DirectSD90322306SD903223062026-10-15
B382SD903454040Surgical DirectSD90345404SD903454042026-10-15
B382SD903454060Surgical DirectSD90345406SD903454062026-10-15
B382SD911434070Surgical DirectSD91143407SD911434072026-10-15
B382SD914174550Surgical DirectSD91417455SD914174552026-10-15
B382SD9141781090Surgical DirectSD914178109SD9141781092026-10-15
B382SD9141781620Surgical DirectSD914178162SD9141781622026-10-15
B382SD914603200Surgical DirectSD91460320SD914603202026-10-15
B382SD920761000Surgical DirectSD92076100SD920761002026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493441665RIVA Pedicle Screw SystemXENIX MEDICAL LLCHXB2026-10-05
00840493441719RIVA Pedicle Screw SystemXENIX MEDICAL LLCHXB2026-10-05
00840606191302PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00840606191319PrimusSPINAL ELEMENTS, INC.HXB2026-09-22
00850088713558PRINCETONPrinceton Medical Group, Inc.HXB2026-08-14
B382SD9213821020Surgical DirectSurgical Direct, Inc.HXB2026-08-07
B382SD483800190Surgical DirectSurgical Direct, Inc.HXB2026-08-03
00840606191593Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191869Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840606191876Overwatch PCFSPINAL ELEMENTS, INC.HXB2026-07-31
00840183532383BR Surgical, LLCBR Surgical, LLCHXB2026-07-21
18257200046706FIREBIRD SFS,SPECIAL PRODUCTSOrthofix US LLCHXB2026-07-17
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095BENCOXCorentec Co., LtdHXB2026-04-10
10888857578197Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578203Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578630Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578647Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578654Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578661Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20
10888857578678Vulcan™ Spinal SystemVB Spine LLCHXB2026-02-20