Medline
LHK, US, Colorado Springs Card
1manufacturer
11catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OHD |
| Device type | Gynecological Laparoscopic Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2016-10-14 |
| Record revised | 2022-06-17 (version 3) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 12, case of 15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDH1053 | In distribution | |
| CDS983410G | In distribution | |
| DYNJ38401J | In distribution | |
| P674136 | In distribution | |
| CDS982915N | In distribution | |
| P584356 | In distribution | |
| SPEC0293 | In distribution | |
| VASC1899 | In distribution | |
| CDS983032P | In distribution | |
| CDS760059G | In distribution | |
| CDS982904K | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16,238 |
| Medline Industries, Inc. | Medline Industries, Inc. | 6,429 |
| ACS | American Contract Systems, Inc. | 739 |
| Aligned Medical Solutions | Aligned Medical Solutions | 112 |
| Regard™ | ROi CPS LLC | 71 |
| DeRoyal | Deroyal Industries, Inc. | 42 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 26 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 15 |
| BR Surgical, LLC | BR Surgical LLC | 15 |
| Medical Action Industries | Medical Action Industries, Inc. | 13 |
| Halyard | Avid Medical, Inc. | 7 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 4 |
Showing 12 of 14. All products under Gynecological Laparoscopic Kit
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.