FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD13798330
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD13798-33
Catalog number
SD13798-33
Device description
5mm Bariatric Length Fenestrated Grasper, Micro 10mm Jaw, Locking Reinforced, Carbon Fiber Handle, with Cleaning Port
Published
2026-10-06
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
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD13798330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic tissue manipulation forceps/working-channelA rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. 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
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
B382SD134188100Surgical DirectSD13418-810SD13418-8102026-10-06
B382SD6520450Surgical DirectSD65-2045SD65-20452026-10-06
B382SD6562120Surgical DirectSD65-6212SD65-62122026-10-06
B382SD902866230Surgical DirectSD90286623SD902866232026-10-06
B382SD905582180Surgical DirectSD90558218SD905582182026-10-06
B382SD9056791090Surgical DirectSD905679109SD9056791092026-10-06
B382SD9056791170Surgical DirectSD905679117SD9056791172026-10-06
B382SD915598230Surgical DirectSD91559823SD915598232026-10-06
B382SD56534330Surgical DirectSD56534-33SD56534-332025-09-10
B382SD4830050Surgical DirectSD48-3005SD48-30052025-12-08
B382SD9141792000Surgical DirectSD914179200SD9141792002024-06-24
B382SD907186100Surgical DirectSD90718610SD907186102023-04-24
B382SD934496030Surgical DirectSD93449603SD934496032023-02-22
B382SD917665010Surgical DirectSD91766501SD917665012022-12-01
B382SD934496020Surgical DirectSD93449602SD934496022022-12-01
B382SD1618230Surgical DirectSD161823SD1618232022-11-23
B382SD161824530Surgical DirectSD16182453SD161824532022-11-23
B382SD413690Surgical DirectSD41369SD413692020-04-27
B382SD232590Surgical DirectSD23259SD232592020-04-25
B382SD9344181000Surgical DirectSD934418100SD9344181002026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083812AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083843AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083874AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083898AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084963AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084970AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657087698AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25