FDA.reportPublic FDA data

LiNA OperaScope™ Biopsy Forceps

Primary DI
05708265012442
Brand
LiNA OperaScope™ Biopsy Forceps
Company
Lina Medical ApS
Model
OP-FCP-6
Catalog number
OP-FCP-6
Device description
Alligator Biopsy Forceps for hysteroscopy and cystoscopy. Minimum channel diameter: Ø2.0mm.
Published
2020-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265012459PackageGS16In Commercial Distribution
05708265012442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265012459057082650124595708265012459
05708265012442057082650124425708265012442

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, single-useA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+48 612222149info.poland@lina-medical.com

Regulatory Flags#

DUNS number
305088619
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708265000241EpiGuard81702023-06-07
05708265000890Drain Guard81502023-06-07
05708265005109Pleura-Guard81612023-06-07
05708265014095LiNA CystoVu™ HD Biopsy Forceps CYV-FCP-5 2025-04-18
05708265014118LiNA CystoVu™ HD GrasperCYV-GRA-52025-04-18
05708265014101LiNA CystoVu™ HD Biopsy Forceps CYV-FCP-5 2025-04-18
05708265014125LiNA CystoVu™ HD GrasperCYV-GRA-52025-04-18
05708265012466LiNA OperaScope™ Rat Tooth Alligator GrasperOP-GRA-6OP-GRA-62020-09-04
05708265013319LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-1MOR-1515-12024-09-24
05708265013326LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-1MOR-1515-12024-09-24
05708265013333LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-6MOR-1515-62024-09-23
05708265013968LiNA CystoVu™ HDCYV-101-52024-09-23
05708265013340LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-6MOR-1515-62024-09-23
05708265013944LiNA CystoVu™ HDCYV-100-52024-09-23
05708265013975LiNA CystoVu™ HDCYV-101-52024-09-23
05708265014002LiNA ScopeVu™ SCP-100-12024-09-23
05708265004508LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-1MOR-1515-12016-09-15
05708265010219LiNA OperaScope™ Rat Tooth Alligator GrasperOP-GRA-6OP-GRA-62018-04-11
05708265010301LiNA OperåScope™ with HDMI cable & LCD OP-201-6OP-201-62018-02-21
05708265010943LiNA OperåScope™ with HDMI cable & LCD OP-201-6OP-201-62018-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435356MillenniumAvalign Technologies, Inc.HTD2026-10-19
00190776435158MillenniumAvalign Technologies, Inc.HTD2026-10-16
00192896123878Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123885Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123892Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123908Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123915Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00190776434717MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434748MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434755MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434243MillenniumAvalign Technologies, Inc.HTD2026-10-09
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD918660100Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07
G1415140730Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G1415141510Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141514271180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141549012180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
00192896123793Adson Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123809Micro Skinner ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123823Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123830Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123847Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14152810910Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30