FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD482036PH0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD48-2036PH
Catalog number
SD48-2036PH
Device description
3.4mm 125mm Scissor Punch, Straight, Pro Handle
Published
2026-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD482036PH0PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

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
B382SD488603LH0Surgical DirectSD48-8603LHSD48-8603LH2026-09-23
B382SD914763020Surgical DirectSD91476302SD914763022026-10-30
B382SD05600Surgical DirectSD0560SD05602020-04-26
B382SD402590Surgical DirectSD40259SD402592026-11-03
B382SD429490Surgical DirectSD42949SD429492026-11-03
B382SD62031510Surgical DirectSD62-031-51SD62-031-512026-11-04
B382SD89259100Surgical DirectSD8925-910SD8925-9102026-11-03
B382SD89519020Surgical DirectSD8951-902SD8951-9022026-11-03
B382SD902171200Surgical DirectSD90217120SD902171202026-11-04
B382SD9146531600Surgical DirectSD914653160SD9146531602026-11-04
B382SD9146531620Surgical DirectSD914653162SD9146531622026-11-04
B382SD9146531630Surgical DirectSD914653163SD9146531632026-11-04
B382SD9146531640Surgical DirectSD914653164SD9146531642026-11-04
B382SD9152181060Surgical DirectSD915218106SD9152181062026-11-03
B382SD9152181070Surgical DirectSD915218107SD9152181072026-11-03
B382SD9180201110Surgical DirectSD918020111SD9180201112026-11-04
B382SD921171120Surgical DirectSD92117112SD921171122026-11-03
B382SD921171190Surgical DirectSD92117119SD921171192026-11-03
B382SD922864110Surgical DirectSD92286411SD922864112026-11-03
B382SD922864120Surgical DirectSD92286412SD922864122026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437886MillenniumAvalign Technologies, Inc.NBH2026-11-04
B382SD429490Surgical DirectSurgical Direct, Inc.NBH2026-11-03
04066524011751Trocar, sharp, Ø 2.9 mmXION GmbHNBH2026-10-29
04066524011768Obturator, blunt, conical, Ø 2.9 mmXION GmbHNBH2026-10-29
04066524011775Trocar sheath, Ø 3.8 mm, 1 stopcock, rotatable, 0°XION GmbHNBH2026-10-29
04066524011782Trocar sheath, Ø 3.8 mm, 1 stopcock, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011799Trocar sheath, Ø 3.8 mm, 2 stopcocks, rotatable, 0°XION GmbHNBH2026-10-29
04066524011805Trocar sheath, Ø 3.8 mm, 2 stopcocks, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011812Trocar, sharp, Ø 4.2 mmXION GmbHNBH2026-10-29
04066524011829Obturator, conical, blunt, Ø 4.2 mmXION GmbHNBH2026-10-29
04066524011836Trocar sheath, Ø 6 mm, 1 stopcock, 0°XION GmbHNBH2026-10-29
04066524011843Trocar sheath, Ø 6 mm, 1 stopcock, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011850Trocar sheath, Ø 6 mm, 2 stopcocks, rotatable, 0°XION GmbHNBH2026-10-29
04066524011867Trocar sheath, Ø 6 mm, 2 stopcocks, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011874Trocar sheath, Ø 6.5 mm, 1 stopcock, rotatable, 0°XION GmbHNBH2026-10-29
04066524011881Trocar sheath, Ø 6.5 mm, 1 stopcock, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011898Trocar sheath, Ø 6.5 mm, 2 stopcocks, rotatable, 0°XION GmbHNBH2026-10-29
04066524011904Trocar sheath, Ø 6.5 mm, 2 stopcocks, rotatable, 30°/70°XION GmbHNBH2026-10-29
04250337112860Closing Cap for joimax® endoscopesJoimax GmbHNBH2026-10-29
04250337121084HofHolderJoimax GmbHNBH2026-10-29
04250337121107HofHolderJoimax GmbHNBH2026-10-29
04250337121114HofHolderJoimax GmbHNBH2026-10-29
04250337121121HofHolderJoimax GmbHNBH2026-10-29
04250337121138HofHolderJoimax GmbHNBH2026-10-29
04250337121145HofHolderJoimax GmbHNBH2026-10-29
04250337121152HofHolderJoimax GmbHNBH2026-10-29
04250337121169HofHolderJoimax GmbHNBH2026-10-29
04250337121985Reduction Tube for Laminoscope DeltaJoimax GmbHNBH2026-10-29
04250337122098Closing Cap for joimax® EndoscopesJoimax GmbHNBH2026-10-29
04250337122357Reduction Tube for Laminoscope DeltaJoimax GmbHNBH2026-10-29