| Primary Device ID | B924162381 |
| NIH Device Record Key | d90de260-ab05-4d7f-9d8b-7df0304feef9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CROWN SURGICAL |
| Version Model Number | NEEDLE HOLDER |
| Catalog Number | 16-238 |
| Company DUNS | 645681094 |
| Company Name | CROWN SURGICAL CORPORATION |
| Device Count | 25 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM | |
| Phone | 15162927400 |
| MIRZA@FINESURGICAL.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B924162380 [Primary] |
| HIBCC | B924162381 [Unit of Use] |
| HIBCC | B924162382 [Package] Contains: B924162380 Package: CARDBOARD BOX [600 Units] In Commercial Distribution |
| FHQ | Holder, Needle, Gastroenterologic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
[B924162381]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-10 |
| Device Publish Date | 2021-03-02 |
| B924121912 | KELLY-RANKIN Hemostatic Forceps, Curved 6-1/4" |
| B92412189DB2 | KELLY Hemostatic Forceps, Curved, 5-1/2" |
| B92412183AM2 | HALSTEAD Mosquito Forceps, Curved, 5" SATIN |
| B92412182S2 | HALSTEAD Mosquito Forceps, Straight, 5" SATIN |
| B92412182AM2 | HALSTEAD Mosquito Forceps, Straight, 5" |
| B92411177BXBK2 | UTILITY (EMT) Shears, Autoclavable, Assorted Colors (Economy), 7-1/2" BLACK |
| B92411138DBPP2 | IRIS Scissors, Straight, 4-1/2" |
| B92411107DBSB2 | Operating Scissors, Straight, Sharp/Blunt, 5-1/2" |
| B92402447DB2 | MAGILL Catheter Introducing Forceps, Adult Size, 9-3/4" |
| B924193501 | ADSON Tissue Forceps, 1 x 2 teeth, 4-3/4" |
| B924193491 | ADSON Dressing Forceps, Serrated, 4-3/4" |
| B924162901 | MAYO-HEGAR Needle Holder, 8" |
| B924162881 | MAYO-HEGAR Needle Holder, 7" |
| B92416287SM1 | MAYO-HEGAR Needle Holder, 6" SMOOTH |
| B924162861 | MAYO-HEGAR Needle Holder, 5-1/2" |
| B92416285A1 | BAUMGARTNER Needle Holder, Serrated, 5-1/2" |
| B92416274LRS1 | WEBSTER Needle Holder, Smooth Jaws, Fine Points, Satin, 6" |
| B92416254LR1 | WEBSTER Needle Holder, Smooth Jaws, 5" |
| B924132431 | LORNA Towel Clamps, Non-Penetrating 5-1/4" |
| B92412183FP1 | HALSTEAD Mosquito Forceps, Curved, 5" FINE POINT |
| B92412182FP2 | HALSTEAD Mosquito Forceps, Straight, 5" FINE POINT |
| B92411176BXBK2 | UTILITY (EMT) Shears, Autoclavable, Assorted Colors (Economy), 5-1/2" BLACK |
| B92412222DB2 | Rochester Carmalt Hemo Forceps 6-1/4" Curved |
| B924122022 | Rochester Pean Hemo Forceps 8" Straight |
| B92412201DB2 | Rochester Pean Hemo Forceps 7-1/4" Curved |
| B924122012 | Rochester Pean Hemo Forceps 7-1/4" Curved |
| B92412200DB1 | ROCHESTER-PEAN Hemostatic Forceps, Straight, 7-1/4" |
| B924122002 | Rochester Pean Hemo Forceps 7-1/4" Straight |
| B924121942 | Crile Hemo Forceps 6-1/4" Straight |
| B924121922 | CRILE Hemostatic Forceps, Straight 5-1/2" |
| B924121892 | KELLY Hemostatic Forceps, Curved, 5-1/2" |
| B92412188DB2 | KELLY Hemostatic Forceps, Straight, 5-1/2" |
| B92412183DB2 | HALSTEAD Mosquito Forceps, Curved, 5" |
| B924121832 | HALSTEAD Mosquito Forceps, CURVED, 5" |
| B924121822 | HALSTEAD Mosquito Forceps, Straight, 5" |
| B924121812 | Mosquito Hemo Forceps 3-1/2" CURVED |
| B924121802 | Mosquito Hemo Forceps 3-1/2" Straight |
| B924111812 | LITTAUER Stitch Scissors, Small, 4-1/2" |
| B92411138PP2 | IRIS Scissors, Straight, 4-1/2" PP BULK |
| B92411116DB2 | MAYO Dissecting Scissors, Curved, 5-1/2" |
| B924111160 | MAYO Dissecting Scissors, Cvd, 5-1/2" |
| B92411105SB2 | Operating Scissors 4-1/2" SH/BL Straight |
| B92415268DB1 | VORSE (U.S. Pattern) Tube Occluding Clamp, Straight, Serrated, 7-1/2" |
| B924162641 | WEBSTER Needle Holder, 1/2 Serrated Jaws, Fine Points, 5" |
| B924162582 | WEBSTER N/H, Sm Jaws, FP, Satin 5" |
| B92416256PP2 | WEBSTER N/H, Sm Jaws, FP, 5" PP |
| B92416254DB1 | WEBSTER N/H, Sm Jaws 5" |
| B924162381 | DERF Needle Holder, 4-3/4" |
| B924132401 | BACKHAUS Towel Clamps 3-1/2" |
| B924122362 | SCHNIDT Tonsil Hemostatic Forceps, Slight Curve, 7-1/2" |