FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD905701100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD90570110
Catalog number
SD90570110
Device description
8 1/4” Ryder Castroviejo Needle Holder, TC
Published
2026-07-23
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
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD905701100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor 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
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
B382SD155310120Surgical DirectSD15531012SD155310122026-07-23
B382SD155310140Surgical DirectSD15531014SD155310142026-07-23
B382SD1553600Surgical DirectSD155360SD1553602026-07-23
B382SD9017971040Surgical DirectSD901797104SD9017971042026-07-23
B382SD9029931060Surgical DirectSD902993106SD9029931062026-07-23
B382SD9114061030Surgical DirectSD911406103SD9114061032026-07-23
B382SD911424030Surgical DirectSD91142403SD911424032026-07-23
B382SD911424050Surgical DirectSD91142405SD911424052026-07-23
B382SD911424060Surgical DirectSD91142406SD911424062026-07-23
B382SD9114241000Surgical DirectSD911424100SD9114241002026-07-23
B382SD9114251000Surgical DirectSD911425100SD9114251002026-07-23
B382SD91143009NC0Surgical DirectSD91143009NCSD91143009NC2026-07-23
B382SD9114301120Surgical DirectSD911430112SD9114301122026-07-23
B382SD91143012NC0Surgical DirectSD91143012NCSD91143012NC2026-07-23
B382SD9114311010Surgical DirectSD911431101SD9114311012026-07-23
B382SD9114311060Surgical DirectSD911431106SD9114311062026-07-23
B382SD9114311080Surgical DirectSD911431108SD9114311082026-07-23
B382SD911437070Surgical DirectSD91143707SD911437072026-07-23
B382SD91143709NC0Surgical DirectSD91143709NCSD91143709NC2026-07-23
B382SD9114511000Surgical DirectSD911451100SD9114511002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183531980BR Surgical, LLCBR Surgical, LLCFHQ2026-07-22
00190776403751MillenniumAvalign Technologies, Inc.FHQ2026-07-21
00840183531720BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532475BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532499BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00190776397104MillenniumAvalign Technologies, Inc.FHQ2026-07-16
04059453084217Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-07-16
00810055258567Surgical DesignSurgical Design, Inc.FHQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.FHQ2026-06-22
00810055251544Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810055251551Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810212931654SURGIPROSSurgipros, LLCFHQ2026-06-01
00810055250721Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250738Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250745Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250752Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250783Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250790Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250806Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250813Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250820Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250844Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250851Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250882Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250905Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250912Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450028Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450035Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450066Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450073Surgical DesignSurgical Design, Inc.FHQ2026-05-29