FDA.report

TLC Self-Retaining Retractor System

Primary DI
00842071144487
Brand
TLC Self-Retaining Retractor System
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ETLC090-50
Catalog number
ETLC090-50, TLC090-50
Device description
TLC Retractor Stay, 3 mm, Sharp Hook, 1-pk (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

Related Records

Contact Domains

Product Codes

CodeName
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842071144487PackageGS150In Commercial Distribution
00842071144234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071144487008420711444878420711444870842071144487
00842071144234008420711442348420711442340842071144234

GMDN Terms

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 a 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

Contacts

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

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