FDA.reportPublic FDA data

TLC Self-Retaining Retractor System

Primary DI
00842071119348
Brand
TLC Self-Retaining Retractor System
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
TLC5013
Device description
TLC Male Urology Retractor System without Frame (Boxed)
Published
2018-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00842071119348PreviousGS10
00842071119591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071119348008420711193488420711193480842071119348
00842071119591008420711195918420711195910842071119591

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, single-useA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146290MINI Balloon Button5-14605-14602026-09-29
00842071146306MINI Balloon Button5-1460-I5-1460-I2026-09-29
00842071146313MINI Balloon Button5-14655-14652026-09-29
00842071146320MINI Balloon Button5-1465-I5-1465-I2026-09-29
00842071146351MINI Balloon Button5-16125-16122026-09-29
00842071146368MINI Balloon Button5-1612-I5-1612-I2026-09-29
00842071146399MINI Balloon Button5-16175-16172026-09-29
00842071146405MINI Balloon Button5-1617-I5-1617-I2026-09-29
00842071146450MINI Balloon Button5-16255-16252026-09-29
00842071146467MINI Balloon Button5-1625-I5-1625-I2026-09-29
00842071146511MINI Balloon Button5-16355-16352026-09-29
00842071146528MINI Balloon Button5-1635-I5-1635-I2026-09-29
00842071146559MINI Balloon Button5-16445-16442026-09-29
00842071146566MINI Balloon Button5-1644-I5-1644-I2026-09-29
00842071146597MINI Balloon Button5-18125-18122026-09-29
00842071146603MINI Balloon Button5-1812-I5-1812-I2026-09-29
00842071146436MINI Balloon Button5-16235-16232026-07-17
00842071146443MINI Balloon Button5-1623-I5-1623-I2026-07-17
00842071153083NutraGlide Nasal Feeding TubeENFT-05055-IENFT-05055-I, NFT-05055-I2026-06-10
00842071153106NutraGlide Nasal Feeding TubeENFT-05090-IENFT-05090-I, NFT-05090-I2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433086MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433116MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433154MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572108210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157211460Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157212010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157213040Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
00190776432874MillenniumAvalign Technologies, Inc.GAD2026-09-29
00190776432515MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432591MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432621MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432638MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432669MillenniumAvalign Technologies, Inc.GAD2026-09-28
00840329838829N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329838980N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839000N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839017N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24