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 |