UNIFY Nylon Surgical Sutures

GUDID 10814639020141

Nylon, 3-0, 19mm 3/8 circle Rev Cut, 30"

APPLIED DENTAL, INC.

Nylon suture, non-bioabsorbable, monofilament
Primary Device ID10814639020141
NIH Device Record Key528aca21-c421-42e6-bbba-f08859d5019f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY Nylon Surgical Sutures
Version Model NumberM-N330R19
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 Latexfalse
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
GS100814639020144 [Primary]
GS110814639020141 [Package]
Contains: 00814639020144
Package: Box [12 Units]
In Commercial Distribution
GS120814639020148 [Package]
Package: case [100 Units]
In Commercial Distribution

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2015-08-07

On-Brand Devices [UNIFY Nylon Surgical Sutures]

20814639023606UNIFY Nylon Surgical Sutures, XXS 10-0, 6.5mm 3/8 circle Rev Cut, 7"
20814639023590Nylon Surgical Biopsy Sutures , 4-0, 13mm 3/8 circle Rev Cut, 10"
20814639023255Nylon Sutures, Size 2, 40mm Taper Point, 30".
20814639023194Nylon Sutures, 2/0, 60mm Straight Cutting, 30".
20814639022616Nylon, 5-0, 16mm 3/8 circle Rev Cut, 18"
40814639022603Nylon, 4-0, 16mm 3/8 circle Rev Cut, 18"
10814639021674UNIFY Nylon Surgical Sutures
10814639021667UNIFY Nylon Surgical Sutures, Size10-0, 6.4mm 3/8 Circle Spatula Double Micro-Needle, 12"
10814639020288UNIFY Nylon Surgical Sutures, XS 6-0, 11mm 3/8 circle Rev Cut, 18"
10814639020271UNIFY Nylon Surgical Sutures, XL 2-0, 36mm 1/2 Cir Taper Pt, 30"
10814639020264UNIFY Nylon Surgical Sutures, XL 0, 36mm 1/2 Cir Taper Pt, 30"
10814639020257UNIFY Nylon Surgical Sutures, XL 0, 30mm 3/8 circle Rev Cut, 30"
10814639020240Nylon Surgical Biopsy Sutures, 6-0, 13mm 3/8 circle Rev Cut, 10"
10814639020233Nylon Surgical Sutures, 6-0, 13mm 3/8 circle Rev Cut, 18"
10814639020226Nylon Surgical Biopsy Sutures , 5-0, 13mm 3/8 circle Rev Cut, 10"
10814639020219Nylon Suture, 5-0, 13mm 3/8 circle Rev Cut, 18"
10814639020202Nylon, 4-0, 13mm 3/8 circle Rev Cut, 18"
10814639020196Nylon, 5-0, 19mm 3/8 circle Rev Cut, 18"
10814639020189Nylon Biopsy, 5-0, 19mm 3/8 circle Rev Cut, 10"
10814639020172Nylon, 4-0, 19mm 3/8 circle Rev Cut, 30"
10814639020165Nylon, 4-0, 19mm 3/8 circle Rev Cut, 18"
10814639020158Nylon Biopsy, 4-0, 19mm 3/8 circle Rev Cut, 10"
10814639020141Nylon, 3-0, 19mm 3/8 circle Rev Cut, 30"
10814639024149UNIFY Nylon Ultra-Premium Microsutures , XXS 10-0, 4mm taper Point, 5"
10814639024132UNIFY Nylon Ultra-Premium Microsutures , XXS 9-0, 5mm taper Point, 5"
10814639024125Ultra-Premium Microsutures Nylon Size 7.0 Spatula needle, 13mm, 18".
10814639025665Nylon Surgical Sutures, 6-0, 13mm 3/8 circle Rev Cut, 18" 3 DZN Pack
10814639025658Nylon Suture, 5-0, 13mm 3/8 circle Rev Cut, 18" 3 DZN Pack
10814639025634Nylon, 5-0, 19mm 3/8 circle Rev Cut, 18" 3 DZN Pack
10814639025610Nylon, 4-0, 19mm 3/8 circle Rev Cut, 18" 3 DZN Pack
10814639023333Nylon Sutures, 4-0, 13mm 3/8 circle Rev Cut, 18". Black. 1 Pc of the 3 Dzn.
10814639023326Nylon Biopsy Sutures , 4-0, 19mm 3/8 circle Rev Cut, 10" Black. 1 pc of 36

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.