TLC Support Strap

Primary DI
00842071109363
Brand
TLC Support Strap
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ETLC010
Device description
Small Support Strap (Sterile, Pouched)
Published
2018-09-30
Public version status
Update
Distribution status
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
00842071111830PackageGS110In Commercial Distribution
00842071109363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071111830008420711118308420711118300842071111830
00842071109363008420711093638420711093630842071109363

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

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00842071146276MINI Balloon Button5-14555-14552026-04-09
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00842071151140RHAPSOESD110-C-07ESD110-C-07, SD110-C-07-101, SD110-C-07-1052026-03-25
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00842071150952AMT MiniSPC Drainage SetES1-1221ES1-1221, S1-12212026-03-18
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00842071152758MiniSPC ButtonSPC-2425-12SPC-2425-122026-03-18
00842071152765MiniSPC ButtonSPC-2425-24SPC-2425-242026-03-18
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00842071152802MiniSPC ButtonSPC-2430-24SPC-2430-242026-03-18

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