Teleflex
Green Polyglycolic Acid Braid Size 0 two TC-43 needles 48" BSC
4manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2021-04-01 |
| Record revised | 2026-02-04 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at Room Temperature |
| Packaging | Box of 12, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN056768 | Suture Length 36″, Needle 1 Length 0.160″, Needle 2 Length 1.030″ | In distribution |
| 833-245 | Suture Length 48″, Two Needle Lengths @ 0.160″ | In distribution |
| IPN928575 | Suture Length 48″, Two Needle Lengths @ 0.160″ | In distribution |
| IPN056769 | Suture Length 48″, Two Needle Lengths @ 0.160″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060801 | 2006-05-17 |
| K042141 | 2004-09-28 |
| K033115 | 2003-11-17 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-03-11 | Class II | Other | The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. | 7,380 ea (total) | 2016-03-29 |
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2010-02-01 | Not classified | Labeling mix-ups | Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box. | 17 sales units (24 packs per sales unit/408 units) | 2011-04-19 |
| 2010-02-01 | Not classified | Labeling mix-ups | Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box. | 17 sales units (24 packs per sales unit/408 units) | 2011-04-19 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
| 2007-06-06 | Not classified | Other | Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. | 1920 units total for all types of sutures | 2008-03-14 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | Davis & Geck, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.