FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867041257
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-7199
Catalog number
AR-7199
Device description
FINGERSHIELDS
Published
2017-02-15
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
LZBFinger cot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZBFinger CotGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052387000ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XXArthrex, Inc.2005-11-29LZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867041254PackageGS110In Commercial Distribution
00888867041257PrimaryGS10
M150AR71991SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886704125410888867041254
00888867041257008888670412578888670412570888867041257

GMDN Terms#

Term, Definition table
TermDefinition
Surgical finger guardA cap intended to be placed over the gloved, non-dominant index finger of a surgical staff hand to provide protection from blood contamination and to reduce accidental needle-sticks and scalpel cuts during a surgical procedure. It is a tough, thimble-like shell with a repellent surface designed with specific features (e.g., notches, protrusions) to help guide a needle tip insertion while protecting the fingertip of the wearer. It is typically used for blunt tissue dissection, to prevent blood vessel punctures, and for interventions such as bladder neck suspension, episiotomy repair and colporrhaphy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867050037Arthrex®AR-8933L-14SAR-8933L-14S2017-08-31
00888867050051Arthrex®AR-8933L-16SAR-8933L-16S2017-08-31
00888867050075Arthrex®AR-8933L-18SAR-8933L-18S2017-08-31
00888867051324Arthrex®AR-8940-16SAR-8940-16S2017-03-03
00888867051348Arthrex®AR-8940-18SAR-8940-18S2017-03-03
00888867051386Arthrex®AR-8940-22SAR-8940-22S2017-03-03
00888867051447Arthrex®AR-8940-28SAR-8940-28S2017-03-03
00888867051485Arthrex®AR-8940-32SAR-8940-32S2017-03-03
00888867051560Arthrex®AR-8940-40SAR-8940-40S2017-03-03
00888867051584Arthrex®AR-8940-42SAR-8940-42S2017-03-03
00888867053304Arthrex®AR-8945-22FTSAR-8945-22FTS2017-08-31
00888867053496Arthrex®AR-8945-30PTSAR-8945-30PTS2017-08-31
00888867053533Arthrex®AR-8945-32PTSAR-8945-32PTS2017-08-31
00888867053649Arthrex®AR-8945-36PTSAR-8945-36PTS2017-08-31
00888867053687Arthrex®AR-8945-38PTSAR-8945-38PTS2017-08-31
00888867053724Arthrex®AR-8945-40PTSAR-8945-40PTS2017-08-31
00888867053755Arthrex®AR-8945-45FTSAR-8945-45FTS2017-08-31
00888867053816Arthrex®AR-8945-50PTSAR-8945-50PTS2017-08-31
00888867053854Arthrex®AR-8945-55PTSAR-8945-55PTS2017-08-31
00888867053892Arthrex®AR-8945-60PTSAR-8945-60PTS2017-08-31

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Primary DI, Brand, Company table
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10884389105214MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
40884389105215MedlineMEDLINE INDUSTRIES, INC.LZB2024-03-05
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00814889010209Front LineProstat First Aid, LLCLZB2022-10-27
00814889013798Front LineProstat First Aid, LLCLZB2022-10-27
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