FDA.reportPublic FDA data

Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down

Primary DI
10810004820323
Brand
Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down
Company
CLARUS MEDICAL, LLC
Model
35700
Catalog number
35700
Device description
Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down
Published
2024-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810004820326Direct MarkingGS10
10810004820323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004820326008100048203268100048203260810004820326
1081000482032310810004820323

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
763-525-8400admin@clarus-medical.com

Regulatory Flags#

DUNS number
010316284
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810004820125Light Cable, ACMI-Wolf/Dyonics, 1mm5161-1005161-1002024-12-23
10810004820132Light Cable, ACMI-Olympus, 1mm5160-1005160-1002024-12-23
10810004820149Light Cable, ACMI-Storz, 1mm5154-1005154-1002024-12-23
10810004820460Light Cable, ACMI-ACMI, 1mm5161-1005161-1002024-12-30
10810004820705Adapter, ACMI5196-9015196-9012024-12-23
10810004820712Adapter, Olympus5196-9025196-9022024-12-23
10810004820729Adapter, Storz5196-9035196-9032024-12-23
10810004820736Adapter, Wolf/Dyonics5196-9045196-9042024-12-23
10810004820750Universal Light Cable5196-1005196-1002024-12-23
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WC2230-5212230-5212026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WC2230-5132230-5132026-04-21
00810004821118Digital MurphyScope Endoscope2125-5152125-5152026-04-21
B06730000100SOS Shikani Optical Stylet, Adult30000-1030000-102016-09-20
B06730000GL0SOS Malleable Stylet, Green Line (Adult)30000-GL30000-GL2016-09-20
B06730000GLS0SOS Malleable Stylet, Adult, Green Line with Stop30000-GLS30000-GLS2016-09-20
B06730001100SOS Shikani Optical Stylet, Pediatric30001-1030001-102016-09-20
B06730003P0PocketScope, pocket endoscope30003-P30003-P2016-09-20
10810004820170Forceps, Cup, Down, 2mm, 28.5cm3220-0023220-0022024-12-30
10810004820316Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down35701357012024-12-30
10810004820767Forceps, Cup, Down, 2mm, 19.7cm3221-0023221-0022024-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
04250418753395Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753180Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753197Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753203Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753210Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753227Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753234Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753241Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
10381780194354Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194361Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02