FDA.reportPublic FDA data

NA

Primary DI
07613327115147
Brand
NA
Company
STRYKER CORPORATION
Model
0940000000
Catalog number
0940000000
Device description
Cast Cutter
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327115147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327115147076133271151477613327115147

GMDN Terms#

Term, Definition table
TermDefinition
Cast cutter, line-poweredA hand-held, mains electricity (AC-powered) device designed for cutting the plaster or synthetic material used to form casts typically during the removal process. The proximal end is usually cylindrical, forming the handle of the device, whilst the distal end terminates in a rounded, half moon-like, or circular blade capable of cutting the material used to form casts. The cutting capability of the blade is provided by an electric motor in the handle which vibrates or rotates the blade. Cutting is effected by vibration or rotation rather than sawing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795128737Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.HAB2026-01-29
00889795110879APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118400APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118424APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118431APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118448APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795118455APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HAB2026-01-28
00889795128720Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.HAB2026-01-28
10653405990734Hall® Titan™Conmed CorporationHAB2025-12-29
10653405990741Hall® Titan™Conmed CorporationHAB2025-12-29
00885556887165PLATINUMSmith & Nephew, Inc.HAB2024-05-17
00840124510326LapiLockFUSION ORTHOPEDICS, LLCHAB2023-11-01
00840124510333LapiLockFUSION ORTHOPEDICS, LLCHAB2023-11-01
00889795131041FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131058FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131065FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131072FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131089FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131096FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131102FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131119FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131126FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131133FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131140FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131157FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131164FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131171FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131188FJ2000 SystemPARAGON 28, INC.HAB2023-10-25
00889795131195FJ2000 SystemPARAGON 28, INC.HAB2023-10-25