Premium PGLA Sutures

GUDID 10814639023876

Premium PGLA Suture, Size 1, 40mm 1/2 Cir Taper Point, Violet, 27"

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament
Primary Device ID10814639023876
NIH Device Record Key34980440-36b1-442d-9557-e1bedb2272cb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium PGLA Sutures
Version Model NumberPXXL-1G27T40
Company DUNS017524666
Company NameAPPLIED DENTAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639023879 [Primary]
GS110814639023876 [Package]
Contains: 00814639023879
Package: box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-15
Device Publish Date2018-08-13

Devices Manufactured by APPLIED DENTAL, INC.

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10814639026488 - Premium UNIFY Fast Plain Gut Sutures2024-05-29 Premium UNIFY Fast Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Conventional Cut, 18"
10814639026228 - AD Surgical2023-09-15 Disposable Aesthetic Skin Marker. Single Tip 1mm in White Color with ruler and 6 blank labels. Sterile. 1 pc
10814639026235 - SHARD Premium+ IV Catheters2023-09-15 SHARD Premium+ IV Catheters. 18Gx 1.25" with Flashback chamber. Radiopague. Green. Sterile. Single Use.
10814639026242 - SHARD Premium+ IV Catheters2023-09-15 SHARD Premium+ IV Catheters. 20Gx 1" with Flashback chamber. Radiopague. Pink. Sterile. Single Use.

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