FDA.reportPublic FDA data

Intrace USA

Primary DI
00850083275181
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
05-011-115
Catalog number
05-011-115
Device description
Standard Dissecting Thumb Forceps, 1x2 Teeth, 11.5 cm Length, Stainless Steel.
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
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083275181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083275181008500832751818500832751810850083275181

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.

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
00850083275198Intrace USA05-013-14505-013-1452026-07-03
00850083275204Intrace USA05-087-15505-087-1552026-07-03
00850083275211Intrace USA05-203-20005-203-2002026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424503MillenniumAvalign Technologies, Inc.HTD2026-08-07
00841435122925TecometTECOMET INC.HTD2026-08-07
B382SD902508070Surgical DirectSurgical Direct, Inc.HTD2026-08-07
B382SD902509010Surgical DirectSurgical Direct, Inc.HTD2026-08-07
00190776422844MillenniumAvalign Technologies, Inc.HTD2026-08-03
B382SD4121490Surgical DirectSurgical Direct, Inc.HTD2026-08-03
00190776422349MillenniumAvalign Technologies, Inc.HTD2026-07-31
00810143904567SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906158SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906349SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906356SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906448SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931029SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931036SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931043SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931050SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931913SURGIPROSSurgipros, LLCHTD2026-07-31
00810212934907SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935133SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935638SURGIPROSSurgipros, LLCHTD2026-07-31
B382S028531010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S028531030Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S28531800Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S8541010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382SD1355500Surgical DirectSurgical Direct, Inc.HTD2026-07-31
00840277133724Innomed, Inc.INNOMED, INC.HTD2026-07-29
B382SD92022614E0Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9203561000Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9206011020Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B3825SD918621130Surgical DirectSurgical Direct, Inc.HTD2026-07-28