Biosyn
GUDID 20884521033020
Monofilament Absorbable Suture
Covidien LP
Polyester suture, bioabsorbable, monofilament, non-antimicrobial| Primary Device ID | 20884521033020 |
| NIH Device Record Key | b71089be-9677-4ed2-a082-c451f16dd98c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biosyn |
| Version Model Number | SM-431 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
| Length | 18 Inch |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521033023 [Primary] |
| GS1 | 20884521033020 [Package] Contains: 10884521033023 Package: CASE [36 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000037
FDA Product Code
| GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2021-01-29 |
| Device Publish Date | 2015-09-02 |
On-Brand Devices [Biosyn]
| 10884521032880 | Monofilament Absorbable Suture |
| 10884521032286 | Monofilament Absorbable Suture,GS-25,1x Undyed Strand |
| 10884521032712 | Monofilament Absorbable Suture |
| 20884523006107 | Monofilament Absorbable Suture,HOS-11,1x Violet Strand |
| 20884523006091 | Monofilament Absorbable Suture,PC-13,1x Undyed Strand |
| 20884523006084 | Monofilament Absorbable Suture,PC-13,1x Undyed Strand |
| 20884523006077 | Monofilament Absorbable Suture,GS-25,(5),D-Tach,5x Violet Strands |
| 20884523006060 | Monofilament Absorbable Suture,GS-21,(5),D-Tach,5x Undyed Strands |
| 20884523004066 | Monofilament Absorbable Suture,CV-22,1x Violet Strand |
| 20884523004059 | Monofilament Absorbable Suture |
| 20884523004042 | Monofilament Absorbable Suture,BGS-25,(5),D-Tach,5x Violet Strands |
| 20884523004035 | Monofilament Absorbable Suture,GS-21,1x Violet Strand |
| 20884521779089 | Monofilament Synthetic Absorbable Suture |
| 20884521750149 | Monofilament Absorbable Suture |
| 20884521726557 | Monofilament Absorbable Suture |
| 20884521532608 | Monofilament Absorbable Suture, P-12, 1x Undyed Strand |
| 20884521214696 | Monofilament Absorbable Suture, P-13, 1x Undyed Strand |
| 20884521171340 | Monofilament Absorbable Suture,GS-25,1x Violet Strand |
| 20884521164182 | Monofilament Absorbable Suture,GS-21,GS-11,D/A,1x Undyed Strand |
| 20884521164120 | Monofilament Absorbable Suture |
| 20884521164113 | Monofilament Absorbable Suture |
| 20884521163123 | Monofilament Absorbable Suture,KV-34,1x Undyed Strand |
| 20884521154268 | Monofilament Absorbable Suture |
| 20884521153483 | Monofilament Absorbable Suture,HGS-21,1x Violet Strand |
| 20884521143101 | Monofilament Absorbable Suture,GS-21,(5),D-Tach,5x Violet Strands |
| 20884521141060 | Monofilament Absorbable Suture,GU-44,1x Violet Strand |
| 20884521140766 | Monofilament Absorbable Suture,Pre-Cut,6x Violet Strands |
| 20884521140735 | Monofilament Absorbable Suture,V-20,1x Violet Strand |
| 20884521140063 | Monofilament Absorbable Suture |
| 20884521140056 | Monofilament Absorbable Suture,GS-21,GS-11,D/A,1x Undyed Strand |
| 20884521139586 | Monofilament Absorbable Suture,GU-46,D/A,1x Violet Strand |
| 20884521137063 | Monofilament Absorbable Suture,GS-24,Loop,1x Violet Strand |
| 20884521134420 | Monofilament Absorbable Suture |
| 20884521132204 | Monofilament Absorbable Suture,GS-26,Loop,1x Violet Strand |
| 20884521131504 | Monofilament Absorbable Suture,DX-16,1x Undyed Strand |
| 20884521113807 | Monofilament Absorbable Suture,DX-19,1x Undyed Strand |
| 20884521113791 | Monofilament Absorbable Suture,DX-19,1x Undyed Strand |
| 20884521113753 | Monofilament Absorbable Suture,BTV-20,1x Violet Strand |
| 20884521105451 | Monofilament Absorbable Suture,GS-25,Loop,1x Violet Strand |
| 20884521104164 | Monofilament Absorbable Suture,BTP-X,Loop,1x Violet Strand |
| 20884521104140 | Monofilament Absorbable Suture,GS-25,Loop,1x Violet Strand |
| 20884521104133 | Monofilament Absorbable Suture,GS-26,Loop,1x Violet Strand |
| 20884521104126 | Monofilament Absorbable Suture,KV-40,Loop,1x Violet Strand |
| 20884521103020 | Monofilament Absorbable Suture,GS-24,Loop,1x Violet Strand |
| 20884521035345 | Monofilament Absorbable Suture,C-25,1x Violet Strand |
| 20884521033501 | Monofilament Absorbable Suture,GU-46,1x Undyed Strand |
| 20884521033495 | Monofilament Absorbable Suture,GU-46,1x Undyed Strand |
| 20884521033488 | Monofilament Absorbable Suture,CV-22,1x Undyed Strand |
| 20884521033471 | Monofilament Absorbable Suture,GU-46,1x Violet Strand |
| 20884521033464 | Monofilament Absorbable Suture,GU-46,1x Violet Strand |
Trademark Results [Biosyn]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSYN 98048871 not registered Live/Pending |
Willow Tex, LLC 2023-06-19 |
 BIOSYN 86115288 4514794 Live/Registered |
Covidien LP 2013-11-11 |
 BIOSYN 77743999 not registered Dead/Abandoned |
BIOSYN TECNOLOGIA E NUTRIÃÃO ANIMAL LTDA 2009-05-25 |
 BIOSYN 75776685 3233771 Live/Registered |
BIOSYN CORPORATION 1999-08-16 |
 BIOSYN 75521440 3275581 Live/Registered |
Biosyn Corporation 1998-07-20 |
 BIOSYN 75293941 2227265 Live/Registered |
SENTINEL LUBRICANTS, INC. 1997-05-19 |
 BIOSYN 75291554 2192033 Live/Registered |
COVIDIEN LP 1997-05-14 |
 BIOSYN 74707060 not registered Dead/Abandoned |
United States Surgical Corporation 1995-07-28 |
 BIOSYN 74651112 2027755 Live/Registered |
HONEYWELL INTERNATIONAL INC. 1995-03-24 |
 BIOSYN 74272010 1749791 Dead/Cancelled |
BioSyn, Inc. 1992-05-04 |
 BIOSYN 73783994 1693937 Dead/Cancelled |
BIOSYN, INC. 1989-03-02 |
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