FDA.report

SCANLAN® Vascu-Statt Appliers

Primary DI
00846159022575
Brand
SCANLAN® Vascu-Statt Appliers
Company
SCANLAN INTERNATIONAL INC
Model
9009-506M
Catalog number
9009-506M
Device description
THORACOSCOPIC VASCU-STATT APPLIERS (5MM) W/RATCHET STRT JAW 15 1/2" 39.4 cm
Published
2019-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159022575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159022575008461590225758461590225750846159022575

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00846159012002SCANLAN® Titanium Neuro Forceps3003-158-33003-158-32025-05-29
00846159012040SCANLAN® Titanium Neuro Forceps3003-159-33003-159-32025-05-29
00846159012767Scanlan Titanium Bayonet Forceps3003-8403003-8402025-05-29
00846159012798SCANLAN® Titanium Forceps3003-843N3003-843N2025-05-29
00846159013733SCANLAN® Forceps4004-97-3A4004-97-3A2025-05-29
00846159014907SCANLAN® Instruments9009-3609009-3602025-05-29
00846159033229SCANLAN® Neuro Instruments3003-8413003-8412025-05-29
00846159036350SCANLAN® 7007-256-5SC2 7007-256-5SC22025-05-08
00846159036367SCANLAN®7007-252-5SC27007-252-5SC22025-05-08
00846159012576SCANLAN® Titanium Forceps3003-904N3003-904N2025-01-31
00846159012774SCANLAN® Neuro Instruments3003-841N3003-841N2025-01-31
00846159023053SCANLAN® Minimally Invasive Instrumentation9009-360N-12C9009-360N-12C2025-01-31
00846159036251SCANLAN® Titanium Neuro Forceps3003-154-3N3003-154-3N2025-01-31
00846159036268SCANLAN® Titanium Neuro Forceps3003-158-3N3003-158-3N2025-01-31

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