Medline Industries, Inc.
Bgmc General Laparoscopy PK-LF
3manufacturers in China registered for this device type
63catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Hubei (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| PRO-MED (Wuxi)IMP.& Exp.co., Ltd. | Wuxi | Jiangsu | Exporter | 24 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MMO |
| Device type | Tray, Surgical, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2018-08-28 |
| Record revised | 2024-12-12 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 4, case of 2, case of 3, case of 12, case of 5, case of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ0173343F | In distribution | |
| DYNJ901851B | In distribution | |
| DYNJ52152 | In distribution | |
| DYNJ81782 | In distribution | |
| DYNJCH501 | In distribution | |
| DYNDA2034 | In distribution | |
| DYNDA1240 | In distribution | |
| DYNJ901852C | In distribution | |
| DYNJ55955B | In distribution | |
| DYNJ37384C | In distribution | |
| DYNJ53076C | In distribution | |
| DYNJQ0251C | In distribution | |
| CDS983181D | In distribution | |
| DYNDV1962 | In distribution | |
| CDS983582G | In distribution | |
| DYNJ903848A | In distribution | |
| DYNDA1810 | In distribution | |
| DYNJ51677B | In distribution | |
| CDS983173G | In distribution | |
| PHS617605008 | In distribution | |
| DYNJ0796243F | In distribution | |
| DYNJ902288G | In distribution | |
| DYND07800 | In distribution | |
| CDS984591N | In distribution | |
| DYNJ51677A | In distribution | |
| DYND07800 | In distribution | |
| DYNJ27333F | In distribution | |
| DYNJ39211B | In distribution | |
| DYNJ20032F | In distribution | |
| DYNJVB1165 | In distribution | |
| DYNJ62371A | In distribution | |
| DYNJ46504B | In distribution | |
| DYNJ901851D | In distribution | |
| DYNDD1038 | In distribution | |
| DYNJ52152A | In distribution | |
| CDS984318J | In distribution | |
| DYNJ56564 | In distribution | |
| DYNJ37384D | In distribution | |
| CDS984591M | In distribution | |
| DYNDC2046 | In distribution | |
| DYKM2741 | In distribution | |
| DYNJ66160 | In distribution | |
| DYNJ0664747A | In distribution | |
| DYNJ56543 | In distribution | |
| DYNJ0796243D | In distribution | |
| DYNJ54901A | In distribution | |
| DYNJ07936C | In distribution | |
| DYNDA2691 | In distribution | |
| CDS984322D | In distribution | |
| DYNJ903848 | In distribution | |
| DYNJ0982164 | In distribution | |
| DYNJ67789A | In distribution | |
| DYNJ49787A | In distribution | |
| DYNJ46741B | In distribution | |
| DYNJ46504A | In distribution | |
| DYNJ60872B | In distribution | |
| CDS983181C | In distribution | |
| DYNJ44952D | In distribution | |
| DYNJ44952C | In distribution | |
| DYNDA1347 | In distribution | |
| DYNJ38310A | In distribution | |
| DYNJ50425A | In distribution | |
| DYNJ55955 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® | Integra LifeSciences Production Corporation | 16 |
| MicroFrance® | Integra Microfrance SAS | 15 |
| Endoscope container with lid | Spiggle & Theis Medizintechnik Gmbh | 9 |
| Ace Medical Company | Ebner Medical LLC | 7 |
| Integra® | Integra Microfrance SAS | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| Endoscope container with lid, stainless | Spiggle & Theis Medizintechnik Gmbh | 4 |
| ACE Medical | Ebner Medical LLC | 3 |
| Endoscope sterilizing & protecting tray | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Instrument box with cover | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Fentex | Fentex medical GmbH | 2 |
| MicroFrance® | Integra LifeSciences Production Corporation | 2 |
Showing 12 of 62. All products under Tray, Surgical, Ent
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 1294 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 56 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 80 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 86 cases (152 units) |
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.