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
00190776426651MillenniumAvalign Technologies, Inc.LRW2026-08-19
04054462913541evonosevonos GmbH & Co. KGLRW2026-08-19
04054462913572evonosevonos GmbH & Co. KGLRW2026-08-19
04054462913589evonosevonos GmbH & Co. KGLRW2026-08-19
00190776426392MillenniumAvalign Technologies, Inc.LRW2026-08-18
00198506094149ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
00198506094156ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
00198506094163ELMED INCORPORATEDELMED INCORPORATEDLRW2026-08-18
04054462903252evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903269evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903276evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903283evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903306evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903320evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903337evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903344evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903351evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903368evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903375evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903382evonosevonos GmbH & Co. KGLRW2026-08-18
04054462903399evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904648evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904662evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904686evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904693evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904709evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904716evonosevonos GmbH & Co. KGLRW2026-08-18
04054462904730evonosevonos GmbH & Co. KGLRW2026-08-18
04054462907908evonosevonos GmbH & Co. KGLRW2026-08-18
04054462908271evonosevonos GmbH & Co. KGLRW2026-08-18