FDA.reportPublic FDA data

Maryland 45 Degree Inner Shaft 44cm

Primary DI
B354263B0
Brand
Maryland 45 Degree Inner Shaft 44cm
Company
ORANGE SURGICAL INSTRUMENTS, LLC
Model
263B
Catalog number
262B
Published
2018-03-29
Public version status
Update
Distribution status
Not 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
B354263B0PrimaryHIBCC0

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
1
Premarket exempt
true
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
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmOSRP82026-07-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26