FDA.reportPublic FDA data

Suture Closure II 10mm

Primary DI
B354OSSCII10MM3
Brand
Suture Closure II 10mm
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
OSSCII
Device description
Suture Closure II 10mm
Published
2024-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101733000REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIESSac, LLC Dba Pinnacle Medical Surgical2011-06-06GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B354OSSCII10MM3PrimaryHIBCC0
B35400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Peracetic Acid

Regulatory Flags#

DUNS number
047063695
Device count
100
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B3543000012ThoraClear Y Connector3000-012025-11-25
B3543000013ThoraClear Y Connector3000-012025-11-25
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B3543000019ThoraClear Y Connector3000-012025-11-25
B3543000010ThoraClear Y Connector3000-012025-11-25
B354OS3CDBK23 Ring Suture Passer - BariatricOS3CDBK2023-07-07
B354OS3CDBK33 Ring Suture Passer - BariatricOS3CDBK2023-07-07
B3541011Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541012Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541013Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541014Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541015Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541019Duck Bill Forceps Inner Shaft 10mm1012023-07-19
B3541051Biopsy Forceps Inner Shaft 10mm1052023-07-19
B3541052Biopsy Forceps Inner Shaft 10mm1052023-07-19
B3541134Biopsy Forceps with teeth Inner Shaft1132023-07-19
B3541135Biopsy Forceps with teeth Inner Shaft1132023-07-19
B3541139Biopsy Forceps with teeth Inner Shaft1132023-07-19

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