| Primary Device ID | B562PKGS000100 |
| NIH Device Record Key | 8671a4b4-d471-4f4a-81b2-bddf85e0acde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro Surgery Kit |
| Version Model Number | PK-GS0001 |
| Catalog Number | PK-GS0001 |
| Company DUNS | 062355158 |
| Company Name | Wishbone Medical, Inc. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com | |
| Phone | 260-266-7524 |
| carrie.long@redstarcontractmfg.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B562PKGS000100 [Primary] |
| KDD | Kit, Surgical Instrument, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-07 |
| Device Publish Date | 2024-12-30 |
| B562PKGS000100 - Micro Surgery Kit | 2025-01-07Surgical convenience kit provided sterile. |
| B562PKGS000100 - Micro Surgery Kit | 2025-01-07 Surgical convenience kit provided sterile. |
| B562PKGS000200 - Minor Surgery Kit | 2025-01-07 |
| B56251300MDG000G10 - WishBone Plate & Screw System | 2024-01-09 Medium Depth Gauge (65mm) |
| B56211705310200S0 - Smart Correction | 2023-07-03 3.0/200/10mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA |
| B56211705315200S0 - Smart Correction | 2023-07-03 3.0/200/15mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA |
| B56211705320200S0 - Smart Correction | 2023-07-03 3.0/200/20mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA |
| B56211705325200S0 - Smart Correction | 2023-07-03 3.0/200/25mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA |
| B56211705330200S0 - Smart Correction | 2023-07-03 3.0/200/30mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA |