FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9141551000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD914155100
Catalog number
SD914155100
Device description
4 3/4” Lowmann Bone Holding Clamp 1x2 Prong
Published
2026-07-24
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
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9141551000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-fragment manipulator, reusableA hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. 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
B382SD9344181000Surgical DirectSD934418100SD9344181002026-07-10
B382SD9344181010Surgical DirectSD934418101SD9344181012026-07-10
B382SD9344181020Surgical DirectSD934418102SD9344181022026-07-10
B382SD9344181030Surgical DirectSD934418103SD9344181032026-07-10
B382SD921226190Surgical DirectSD92122619SD921226192022-12-01
B382SD070823101310Surgical DirectSD07082-31013-1SD07082-31013-12026-09-30
B382SD13768330Surgical DirectSD13768-33SD13768-332026-09-30
B382SD8160490Surgical DirectSD816049SD8160492026-09-30
B382SD90293310010Surgical DirectSD9029331001SD90293310012026-09-30
B382SD907620220Surgical DirectSD90762022SD907620222026-09-30
B382SD9115011000Surgical DirectSD911501100SD9115011002026-09-30
B382SD914800210Surgical DirectSD91480021SD914800212026-09-30
B382SD9156321100Surgical DirectSD915632110SD9156321102026-09-30
B382SD921329100Surgical DirectSD92132910SD921329102026-09-30
B382SD1455810020Surgical DirectSD14558-1002SD14558-10022026-09-29
B382SD1455810030Surgical DirectSD14558-1003SD14558-10032026-09-29
B382SD30550860Surgical DirectSD30550-86SD30550-862026-09-29
B382SD49195170Surgical DirectSD49195-17SD49195-172026-09-29
B382SD4937851340Surgical DirectSD49-3785-134SD49-3785-1342026-09-29
B382SD546210000Surgical DirectSD5462-1000SD5462-10002026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14152810910Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14154212860Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
00190776432614MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432652MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432683MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432706MillenniumAvalign Technologies, Inc.HTD2026-09-28
00724995323578V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323585V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323608V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323615V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
10886982357298VOLTSynthes GmbHHTD2026-09-25
10886982357304VOLTSynthes GmbHHTD2026-09-25
10886982357311VOLTSynthes GmbHHTD2026-09-25
10886982357328VOLTSynthes GmbHHTD2026-09-25
10886982357854VOLTSynthes GmbHHTD2026-09-25
10886982357861VOLTSynthes GmbHHTD2026-09-25
10886982357878VOLTSynthes GmbHHTD2026-09-25
10886982357885VOLTSynthes GmbHHTD2026-09-25
00810238290063PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00810238290087PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713916PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713930PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713947PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00190776431082MillenniumAvalign Technologies, Inc.HTD2026-09-21
00190776430962MillenniumAvalign Technologies, Inc.HTD2026-09-18
00192896123755Debakey-Diethrich Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-09-18