Primary Device ID | 20814639023644 |
NIH Device Record Key | 5b1c2e43-29a3-4cdb-9022-0db271153dae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UNIFY PTFE Surgical Sutures |
Version Model Number | M-F418R16 |
Catalog Number | M-F418R16 |
Company DUNS | 017524666 |
Company Name | APPLIED DENTAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com | |
Phone | 1-888-841-8481 |
info.usa@AD-Surgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814639023640 [Primary] |
GS1 | 10814639023647 [Package] Contains: 00814639023640 Package: Box [12 Units] In Commercial Distribution |
GS1 | 20814639023644 [Package] Contains: 10814639023647 Package: Case [100 Units] In Commercial Distribution |
NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-09-30 |
20814639023699 | PTFE Sutures, Non-absorbable, 6-0, monofilament, 13mm 3/8 circle Rev Cut, 18" |
20814639023682 | PTFE Sutures, Non-absorbable, 5-0, monofilament, 13mm 3/8 circle Rev Cut, 18" |
20814639023675 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 1/2 circle Taper Point, 18" |
20814639023668 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 3/8 circle Rev Cut, 18" |
20814639023651 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 19mm 3/8 circle Rev Cut, 18" |
20814639023644 | PTFE Sutures, Non-absorbable, 4-0, monofilament, 16mm 3/8 circle Rev Cut, 18" |
20814639023637 | PTFE Sutures, Non-absorbable, 3-0, monofilament, 16mm 3/8 circle Rev Cut, 18" |
20814639023620 | PTFE Sutures, Non-absorbable, 3-0, monofilament, 19mm 3/8 circle Rev Cut, 18" |
00814639023619 | PTFE Sutures, Non-absorbable, 2-0, monofilament, 19mm 3/8 circle Rev Cut, 18" |
10814639024859 | PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30" |
10814639024842 | PTFE Sutures, Non-absorbable, 2-0, monofilament, 60mm straight needle, 30" |
10814639024057 | PTFE Sutures, Non-absorbable, 2-0, monofilament, 36mm 1/2 circle Taper point, 30" |
10814639022237 | PTFE Sutures, Non-absorbable, 5-0, monofilament, 16mm 3/8 circle Rev Cut, 18" |