FDA.reportPublic FDA data

SCANLAN®

Primary DI
00846159030235
Brand
SCANLAN®
Company
SCANLAN INTERNATIONAL INC
Model
3003-954-2
Catalog number
3003-954-2
Device description
SCANLAN® Legacy Forceps Debakey Tips
Published
2022-01-04
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159030235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159030235008461590302358461590302350846159030235

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
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
00846159039931SCANLAN® ScissorsQ2423-7Q2423-72026-05-28
00846159039948SCANLAN® ScissorsQ2428-7Q2428-72026-05-28
00846159039955SCANLAN® ScissorsQ2429-7Q2429-72026-05-28
00846159039962SCANLAN® ScissorsQ2430-7Q2430-72026-05-28
00846159039979SCANLAN® ScissorsQ247-7Q247-72026-05-28
00846159039986SCANLAN® ScissorsQ25010-7Q25010-72026-05-28
00846159039993SCANLAN® ScissorsQ26044-7Q26044-72026-05-28
00846159040005SCANLAN® ScissorsQ27010-7Q27010-72026-05-28
00846159040012SCANLAN® ScissorsQ27065-7Q27065-72026-05-28
00846159040029SCANLAN® ScissorsQ27079-7NQ27079-7N2026-05-28
00846159040036SCANLAN® ScissorsQ27082-7NQ27082-7N2026-05-28
00846159040043SCANLAN® ScissorsQ27119-7Q27119-72026-05-28
00846159040050SCANLAN® ScissorsQ28032-7Q28032-72026-05-28
00846159040067SCANLAN® ScissorsQ28080-7Q28080-72026-05-28
00846159040074SCANLAN® ScissorsQ28097-7Q28097-72026-05-28
00846159040081SCANLAN® ScissorsQ28119-9Q28119-92026-05-28
00846159040098SCANLAN® ScissorsQ29092-9Q29092-92026-05-28
00846159040104SCANLAN® ScissorsQ32034-7NQ32034-7N2026-05-28
00846159040111SCANLAN® ScissorsQ32035-7NQ32035-7N2026-05-28
00846159040128SCANLAN® ScissorsQ33032-7NQ33032-7N2026-05-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
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09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
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09348811010155INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811151162INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
G586D75480250NovosurgicalNOVO SURGICAL, INC.GEN2024-12-30
KTS1017012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1018012K.T.SurgicoK.T.SURGICOGEN2024-02-20
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