FDA.report

Surgical Direct

Primary DI
B382SDP110600
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SDP11060
Catalog number
SDP11060
Device description
54cm Wire Cutting Pliers, TC, up to 6mm
Published
2022-12-03
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

Related Records

Product Codes

CodeName
JEXPLIER, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B382SDP110600PrimaryHIBCC0

GMDN Terms

TermDefinition
ENT wire-cutting scissorsA hand-held manual surgical instrument designed to cut wire intended to construct ossicular replacements for the middle ear. The cutting blades will be more robust than ordinary scissors to tolerate the forces required to cut surgical wire. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B382SD91427410030Surgical DirectSurgical Direct, Inc.JEX2026-02-09
B382SD9142761200Surgical DirectSurgical Direct, Inc.JEX2026-02-09
00190746065477Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746065507Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067426Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067440Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
10190707086494Triumph®Ortho Organizers, Inc.JEX2026-01-07
00190707086503Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086517Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086524Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086531Triumph®Ortho Organizers, Inc.JEX2026-01-07
D9098000041SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800022S1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063C1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063L1ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980007214ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980008417SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980008518SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980023515RAZOROrtho Arch Company IncJEX2025-09-15
D90980023919RAZOROrtho Arch Company IncJEX2025-09-15
D909800239T1RAZOROrtho Arch Company IncJEX2025-09-15
D90980024011RAZOROrtho Arch Company IncJEX2025-09-15
D90980024112RAZOROrtho Arch Company IncJEX2025-09-15
D90980024213RAZOROrtho Arch Company IncJEX2025-09-15
D9098002761ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002771ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002781ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002791ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980013817ORTHO ARCHOrtho Arch Company IncJEX2025-08-27
04963931274291NAYDM CORPORATIONJEX2025-07-11