FDA.report

SCANLAN® Needle Holders

Primary DI
00846159019117
Brand
SCANLAN® Needle Holders
Company
SCANLAN INTERNATIONAL INC
Model
3003-211
Catalog number
3003-211
Device description
Castroviejo Needle Holder Flat Handle
Published
2016-05-20
Public version status
Update
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications

CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159019117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159019117008461590191178461590191170846159019117

GMDN Terms

TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

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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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
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