FDA.reportPublic FDA data

Intrace USA

Primary DI
00850083275273
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
GS-2970/M
Catalog number
GS-2970/M
Device description
Spencer Ligature (Suture) Scissors, Hooked Blade, Fine Tip, 13 cm Length, Stainless Steel, Reusable.
Published
2026-07-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083275273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083275273008500832752738500832752730850083275273

GMDN Terms#

Term, Definition table
TermDefinition
Suture scissorsA hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6124230756info@intrace.us

Regulatory Flags#

DUNS number
110680677
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083275006Intrace USA03-004-14003-004-1402026-07-03
00850083275013Intrace USA03-022-14003-022-1402026-07-03
00850083275037Intrace USA03-097-14503-097-1452026-07-03
00850083275044Intrace USA70-10-2570-10-252026-07-03
00850083275051Intrace USA03-182-11003-182-1102026-07-03
00850083275068Intrace USA03-316-13003-316-1302026-07-03
00850083275075Intrace USA04-002-09004-002-0902026-07-03
00850083275082Intrace USA04-012-12504-012-1252026-07-03
00850083275099Intrace USA04-029-16004-029-1602026-07-03
00850083275105Intrace USA04-030-14004-030-1402026-07-03
00850083275112Intrace USA04-056-20004-056-2002026-07-03
00850083275129Intrace USA04-070-18004-070-1802026-07-03
00850083275136Intrace USA04-082-16004-082-1602026-07-03
00850083275143Intrace USA04-214-18004-214-1802026-07-03
00850083275150Intrace USA04-240-13004-240-1302026-07-03
00850083275167Intrace USA04-273-26004-273-2602026-07-03
00850083275174Intrace USA05-004-14505-004-1452026-07-03
00850083275181Intrace USA05-011-11505-011-1152026-07-03
00850083275198Intrace USA05-013-14505-013-1452026-07-03
00850083275204Intrace USA05-087-15505-087-1552026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427979MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428013MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428136MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428204MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428235MillenniumAvalign Technologies, Inc.LRW2026-08-27
00192896123649Converse ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00192896123656Ferguson Abdominal ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00190776423865MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776423872MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776427634MillenniumAvalign Technologies, Inc.LRW2026-08-26
00846159040845SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040852SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040869SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00190776420383MillenniumAvalign Technologies, Inc.LRW2026-08-25
04058749006032NAFehling Instruments GmbH & Co. KGLRW2026-08-25
04058749047219NAFehling Instruments GmbH & Co. KGLRW2026-08-25
00190776427283MillenniumAvalign Technologies, Inc.LRW2026-08-21
04054462903290evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904624evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904631evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904655evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904679evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904723evonosevonos GmbH & Co. KGLRW2026-08-21
04054462907892evonosevonos GmbH & Co. KGLRW2026-08-21
04054462907915evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908196evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908202evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908219evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908226evonosevonos GmbH & Co. KGLRW2026-08-21
04054462908233evonosevonos GmbH & Co. KGLRW2026-08-21