FDA.reportPublic FDA data

Arbutus Medical

Primary DI
00844107001030
Brand
Arbutus Medical
Company
Arbutus Medical Inc
Model
Digit Revision SwiftKit
Device description
Digit Revision SwiftKit is a surgical procedure kit for digit revision amputations, nail bed repair, or debridement procedures.
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYBMinor Surgical Procedures Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844107001030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844107001030008441070010308441070010300844107001030

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
203296434
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844107001047Arbutus MedicalDigit Revision SwiftKit2026-11-03
00844107001054Arbutus MedicalNailbed Repair SwiftKit2026-11-03
00844107001061Arbutus MedicalNailbed Repair SwiftKit2026-11-03
00844107001078Arbutus MedicalPrecision Laceration SwiftKit2026-11-03
00844107001085Arbutus MedicalPrecision Laceration SwiftKit2026-11-03
00844107001092Arbutus MedicalTrakPak CT Adapter2026-11-03
00844107000996Arbutus MedicalDigit Revision SwiftKit2026-09-24
00844107001009Arbutus MedicalDigit Revision SwiftKit2026-09-24
00844107000897Arbutus MedicalTrakPak2026-06-22
00844107000903Arbutus MedicalTrakPak2026-06-22
00844107000934Arbutus MedicalTrakPak2026-06-22
00844107000958Arbutus MedicalTrakPak2026-06-22
00844107000972Arbutus MedicalTrakPak2026-06-22
00844107000989Arbutus MedicalTrakPak2026-06-22
00844107000736Arbutus MedicalTrakPak2026-04-28
00844107000750Arbutus MedicalTrakPak2026-04-28
00844107000781Arbutus MedicalTrakPak2026-04-28
00844107000804QuikBow QuikBow2026-04-28
00844107000828Arbutus MedicalDigit Revision SwiftKit 2026-04-28
00844107000583Arbutus MedicalSteriTrak2021-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844107001047Arbutus MedicalArbutus Medical IncPYB2026-11-03
00844107001054Arbutus MedicalArbutus Medical IncPYB2026-11-03
00844107001061Arbutus MedicalArbutus Medical IncPYB2026-11-03
00844107001078Arbutus MedicalArbutus Medical IncPYB2026-11-03
00844107001085Arbutus MedicalArbutus Medical IncPYB2026-11-03
00844107000996Arbutus MedicalArbutus Medical IncPYB2026-09-24
00844107001009Arbutus MedicalArbutus Medical IncPYB2026-09-24
00844107000897Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000903Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000934Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000958Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000972Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000989Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000736Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000750Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000781Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000828Arbutus MedicalArbutus Medical IncPYB2026-04-28
00884450116913Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
00884450096529Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
00884450089897Merit Medical®Merit Medical Systems, Inc.PYB2025-05-20
00840365908623InvenioGri-Alleset, Inc.PYB2025-03-12
00884450185261Merit Medical®Merit Medical Systems, Inc.PYB2023-01-04
M7526821425R10STRADIS HEALTHCARESTRADIS MEDICAL, LLCPYB2022-12-22
10197106029916CARDINAL HEALTHCardinal Health 200, LLCPYB2022-11-18
H65857031545Henry ScheinHENRY SCHEIN, INC.PYB2022-08-25
H65857030875Henry ScheinHENRY SCHEIN, INC.PYB2022-05-25
00884450187494Merit Medical®Merit Medical Systems, Inc.PYB2021-10-28
00844107000637Arbutus MedicalArbutus Medical IncPYB2021-10-19
00884450186428Merit Medical®Merit Medical Systems, Inc.PYB2021-03-03
00884450248805Merit Medical®Merit Medical Systems, Inc.PYB2019-10-31