FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD429490
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD42949
Catalog number
SD42949
Device description
3.5mm 130mm Grasper with 1x2 Teeth, Tube Shaft with Cleaning Port
Published
2026-11-03
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
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974382000ACKERMANN SURGICAL INSTRUMENTSAckermann Instrumente GmbH1998-04-21GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD429490PrimaryHIBCC0

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
false
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
B382SD402590Surgical DirectSD40259SD402592026-11-03
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
B382SD922864130Surgical DirectSD92286413SD922864132026-11-03
B382SD9233161140Surgical DirectSD923316114SD9233161142026-11-03
B382SD9340311010Surgical DirectSD934031101SD9340311012026-11-03
B382SD934444110Surgical DirectSD93444411SD934444112026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437886MillenniumAvalign Technologies, Inc.NBH2026-11-04
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
00888867576070Arthrex®ARTHREX, INC.NBH2026-10-20