FDA.reportPublic FDA data

In'tech Medical SAS

Primary DI
03664888000070
Brand
In'tech Medical SAS
Company
IN'TECH MEDICAL
Model
S06ITM200-C628
Device description
TROCAR BLADE
Published
2023-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664888000070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664888000070036648880000703664888000070

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33321896000contact@intech-medical.com

Regulatory Flags#

DUNS number
505965090
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664888000049In'Tech Medical SASS06ITM309-C6282023-12-22
03664888000056In'tech Medical SASS06ITM319-AL-C6282023-12-22
03664888000063In'tech Medical SASMIS223701-3372023-12-22
03664888000087In'tech Medical SASS06ITM378-C6282023-12-22
03664888000094In'tech Medical SASS06ITM279-C6282023-12-22
03664888000100In'tech Medical SASS06ITM340-C6282023-12-22
03664888000117In'tech Medical SASS06ITM350-210-C6282023-12-22
03664888000124In'tech Medical SASS06ITM353-C6282023-12-22
03664888000131In'tech Medical SASS06ITM355-090-L-C6282023-12-22
03664888000148In'tech Medical SASS06ITM355-100-L-C6282023-12-22
03664888000155In'tech Medical SASS06ITM355-110-L-C6282023-12-22
03664888000162In'tech Medical SASS06ITM355-120-L-C6282023-12-22
03664888000179In'tech Medical SASS06ITM355-130-L-C6282023-12-22
03664888000186In'tech Medical SASS06ITM355-140-L-C6282023-12-22
03664888000193In'tech Medical SASS06ITM355-150-L-C6282023-12-22
03664888000209In'tech Medical SASS06ITM355-160-L-C6282023-12-22
03664888000216In'tech Medical SASS06ITM355-170-L-C6282023-12-22
03664888000223In'tech Medical SASS06ITM355-180-L-C6282023-12-22
03664888000230In'tech Medical SASS06ITM355-090-R-C6282023-12-22
03664888000247In'tech Medical SASS06ITM355-100-R-C6282023-12-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038601250ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018420ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018430ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018840ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039030020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601360ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21