FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD483005NH0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD48-3005NH
Catalog number
SD48-3005NH
Device description
5.5mm Irrigation Cannula, No Distal Hole, Luer Lock Connection
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B382SD483005NH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, reusableA collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4Millimeter

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
B382SD9141791080Surgical DirectSD914179108SD9141791082024-03-29
B382SD48820700Surgical DirectSD48-82070SD48-820702023-05-24
B382SD48820070Surgical DirectSD48-82007SD48-820072022-12-02
B382SD48820080Surgical DirectSD48-82008SD48-820082022-12-02
B382SD48820090Surgical DirectSD48-82009SD48-820092022-12-02
B382SD9142211010Surgical DirectSD914221101SD9142211012022-11-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007705STRATOS (Gen2)A.M. SURGICAL, INC.NBH2026-06-05
00857915007033RetraBE Single - Gen 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)A.M. SURGICAL, INC.NBH2026-06-04
00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
00857915007699Locking AttachmentA.M. SURGICAL, INC.NBH2026-05-20
07630345721204Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721211Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721228Surgical Manual InstrumentMedacta International SANBH2026-03-30
10080196385386MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385478MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392032MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392070MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392292MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385218MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-01-29
10845854026946DOUBLELATCHConmed CorporationNBH2023-12-05
10080196387984MedlineMEDLINE INDUSTRIES, INC.NBH2023-10-09
B382SD48820700Surgical DirectSurgical Direct, Inc.NBH2023-05-24
07630345778765Sports Med InstrumentsMedacta International SANBH2023-01-16
07630542702457Sports Med InstrumentsMedacta International SANBH2023-01-16
07613327379624NASTRYKER CORPORATIONNBH2022-12-06
B382SD48820070Surgical DirectSurgical Direct, Inc.NBH2022-12-02
B382SD48820080Surgical DirectSurgical Direct, Inc.NBH2022-12-02
B382SD48820090Surgical DirectSurgical Direct, Inc.NBH2022-12-02
10845854030387Hip Preservation System, PopLokConmed CorporationNBH2022-06-11
10845854028711CONMEDConmed CorporationNBH2021-10-14
10845854029893HIP PRESERVATION SYSTEM SIGNATURE SERIESConmed CorporationNBH2021-10-14
10845854017418Dry-DocConmed CorporationNBH2021-10-12