| Primary Device ID | G165SU210040030 |
| NIH Device Record Key | bc19a8f4-dd5f-4497-9349-bb8c5d3a5813 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Graves Speculum |
| Version Model Number | SU-21-0040-03 |
| Catalog Number | SU-21-0040-03 |
| Company DUNS | 645680588 |
| Company Name | ELMED INSTRUMENTS(PVT)LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G165SU210040030 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-16 |
| Device Publish Date | 2022-09-08 |
| G165SU130176130 - Halsey Needle Holder | 2022-09-19 Intended Use: Halsey needle holders are finger ring forceps that assist surgeons in guiding and inserting suture needles. Packag |
| G165SU130180130 - Webster Needle Holder | 2022-09-19 Intended Use: Webster needle holder is used with small needles and fine suture material, commonly in plastic surgery or subcutan |
| G165SU130184120 - Derf Needle Holder | 2022-09-19 Intended Use: Derf Needle Holders help surgeons to handle and insert suture needles during wound closures. Packaging: Packaging |
| G165SU130196140 - Baumgartner Needle Holder | 2022-09-19 Intended Use: Baumgartner Needle Holder is commonly used for holding long needles and dense suture material. Packaging: Packagin |
| G165SU70275140 - Metzenbaum Scissors | 2022-09-19 Intended Use: Metzenbaum scissors are surgical scissors designed for cutting delicate tissue and blunt dissection. Packaging: Pa |
| G165SU70333180 - Metzenbaum Scissors | 2022-09-19 Intended Use: Metzenbaum Scissors are surgical scissors designed for cutting delicate tissues and blunt dissection Packaging Pac |
| G165SU100095240 - SPONGE FORCEPS | 2022-09-16 Intended Use: To hold gauze squares that will absorb excess fluids and blood. Packaging: Packaging shall be as per customer requ |
| G165SU130206130 - Mayo-Hegar Needle Holder | 2022-09-16 Intended Use: Mayo Hegar Needle Holder is commonly used for holding the suturing needles in several surgical procedures Packagin |