FDA.reportPublic FDA data

TLC Self-Retaining Retractor System

Primary DI
00842071144753
Brand
TLC Self-Retaining Retractor System
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ETLC900
Catalog number
ETLC900, TLC900
Device description
TLC900 TLC Self-Retaining Retractor Frame (Sterile, Pouched), MDR
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
00842071144753PackageGS11In Commercial Distribution
00842071144449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071144753008420711447538420711447530842071144753
00842071144449008420711444498420711444490842071144449

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, single-useA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(440) 717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071153038AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071149932MiniSPC ButtonSPC-1408-12SPC-1408-122026-03-16
00842071149949MiniSPC ButtonSPC-1408-24SPC-1408-242026-03-16
00842071149956MiniSPC ButtonSPC-1410-12SPC-1410-122026-03-16
00842071149963MiniSPC ButtonSPC-14100-12SPC-14100-122026-03-16
00842071149970MiniSPC ButtonSPC-14100-24SPC-14100-242026-03-16
00842071149987MiniSPC ButtonSPC-1410-24SPC-1410-242026-03-16
00842071149994MiniSPC ButtonSPC-1412-12SPC-1412-122026-03-16
00842071150006MiniSPC ButtonSPC-1412-24SPC-1412-242026-03-16
00842071150013MiniSPC ButtonSPC-1415-12SPC-1415-122026-03-16
00842071150020MiniSPC ButtonSPC-1415-24SPC-1415-242026-03-16
00842071150037MiniSPC ButtonSPC-1417-12SPC-1417-122026-03-16
00842071150044MiniSPC ButtonSPC-1417-24SPC-1417-242026-03-16
00842071150051MiniSPC ButtonSPC-1420-12SPC-1420-122026-03-16
00842071150068MiniSPC ButtonSPC-1420-24SPC-1420-242026-03-16
00842071150075MiniSPC ButtonSPC-1423-12SPC-1423-122026-03-16
00842071150082MiniSPC ButtonSPC-1423-24SPC-1423-242026-03-16
00842071150099MiniSPC ButtonSPC-1425-12SPC-1425-122026-03-16
00842071150105MiniSPC ButtonSPC-1425-24SPC-1425-242026-03-16
00842071150112MiniSPC ButtonSPC-1427-12SPC-1427-122026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
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00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
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00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23