FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD92280510120
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD9228051012
Catalog number
SD9228051012
Device description
"7 1/8"" Decker Rongeur, Angled Up, Custom Shaft, 6mm x 2mm Jaw, OL 9"""
Published
2025-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRONGEUR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD92280510120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD484610Surgical DirectSD48461SD484612026-07-09
B382SD484630Surgical DirectSD48463SD484632026-07-09
B382SD484640Surgical DirectSD48464SD484642026-07-09
B382SD484650Surgical DirectSD48465SD484652026-07-09
B382SD484660Surgical DirectSD48466SD484662026-07-09
B382SD484670Surgical DirectSD48467SD484672026-07-09
B382SD484680Surgical DirectSD48468SD484682026-07-09
B382SD484690Surgical DirectSD48469SD484692026-07-09
B382SD484700Surgical DirectSD48470SD484702026-07-09
B382SD484710Surgical DirectSD48471SD484712026-07-09
B382SD484720Surgical DirectSD48472SD484722026-07-09
B382SD49400B0Surgical DirectSD49400BSD49400B2026-07-09
B382SD49401B0Surgical DirectSD49401BSD49401B2026-07-09
B382SD49402B0Surgical DirectSD49402BSD49402B2026-07-09
B382SD49403B0Surgical DirectSD49403BSD49403B2026-07-09
B382SD49404B0Surgical DirectSD49404BSD49404B2026-07-09
B382SD49405B0Surgical DirectSD49405BSD49405B2026-07-09
B382SD49406B0Surgical DirectSD49406BSD49406B2026-07-09
B382SD49407B0Surgical DirectSD49407BSD49407B2026-07-09
B382SD49408B0Surgical DirectSD49408BSD49408B2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
B382SD9238331020Surgical DirectSurgical Direct, Inc.HTX2024-06-25
G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
B382SD921220120Surgical DirectSurgical Direct, Inc.HTX2022-12-01
07640178988750JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640178988767JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640185340602SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340787SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340794SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340800SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340817SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340824SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
00192896078819FERRIS-SMITH KERRISONSONTEC INSTRUMENTS, INC.HTX2018-09-20
10381780194521Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194538Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194545Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02