Device
Digit Revision SwiftKit is a surgical procedure kit for digit revision amputations, nail bed repair, or debridement procedures.
Manufacturer
Arbutus Medical Inc
Arbutus Medical Inc
Model: Digit Revision SwiftKit
DI: 00844107000828
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
Digit Revision SwiftKit is a surgical procedure kit for digit revision amputations, nail bed repair, or debridement procedures.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6d02beb1-e784-420d-8d87-6401f61438a8
Distribution Status:
In Commercial Distribution
DUNS Number:
203296434
Device Count:
6
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
00844107000811
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00844107000828
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44052
Name: Orthopaedic surgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
PYB
Minor Surgical Procedures Tray
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
7
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
29
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
60
Item #2 - Storage Handling Type:
Handling Environment Humidity