FDA.reportPublic FDA data

Allis Grasper Horizontal Teeth Inner Shaft

Primary DI
B354C3971
Brand
Allis Grasper Horizontal Teeth Inner Shaft
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
C397
Device description
Allis Grasper Horizontal Teeth Inner Shaft
Published
2023-07-14
Public version status
Update
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
B354C3971PrimaryHIBCC0
B354397Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Peracetic Acid

Regulatory Flags#

DUNS number
047063695
Device count
5
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3543000011ThoraClear Y Connector3000-012025-11-25
B3543000012ThoraClear Y Connector3000-012025-11-25
B3543000013ThoraClear Y Connector3000-012025-11-25
B3543000014ThoraClear Y Connector3000-012025-11-25
B3543000015ThoraClear Y Connector3000-012025-11-25
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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