FDA.reportPublic FDA data

CUSTOM

Primary DI
03613720222248
Brand
CUSTOM
Company
MEDICREA INTERNATIONAL
Model
A99090600
Device description
LONG STRAIGHT SPATULA
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXRSpatula, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720222248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720222248036137202222483613720222248

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720286714IB3D™ PL Spinal SystemA240002302025-02-24
03613720286677IB3D™ PL Spinal SystemA240000002025-02-21
03613720286684IB3D™ PL Spinal SystemA240002002025-02-21
03613720286707IB3D™ PL Spinal SystemA240002202025-02-21
03613720286202IB3D™ PL Spinal SystemB241C080622092025-02-15
03613720286219IB3D™ PL Spinal SystemB241C090622092025-02-15
03613720286226IB3D™ PL Spinal SystemB241C100622092025-02-15
03613720286233IB3D™ PL Spinal SystemB241C110622092025-02-15
03613720286240IB3D™ PL Spinal SystemB241C120622092025-02-15
03613720286257IB3D™ PL Spinal SystemB241C130622092025-02-15
03613720286264IB3D™ PL Spinal SystemB241C140622092025-02-15
03613720286271IB3D™ PL Spinal SystemB241C150622092025-02-15
03613720286288IB3D™ PL Spinal SystemB241C160622092025-02-15
03613720286295IB3D™ PL Spinal SystemB241C170622092025-02-15
03613720286301IB3D™ PL Spinal SystemB241C091222092025-02-15
03613720286318IB3D™ PL Spinal SystemB241C101222092025-02-15
03613720286325IB3D™ PL Spinal SystemB241C111222092025-02-15
03613720286332IB3D™ PL Spinal SystemB241C121222092025-02-15
03613720286349IB3D™ PL Spinal SystemB241C131222092025-02-15
03613720286356IB3D™ PL Spinal SystemB241C141222092025-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811146700INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
09348811146717INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
14035282341216REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341230REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341278REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341223REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341247REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341254REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341261REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
D105SKU1312100SurgiMac Surgimac LLCHXR2024-04-22
00842517117280Karl SchumacherKarl Schumacher Dental, LLCHXR2024-03-15
00850047707260GillThe Radebaugh-Fetzer CompanyHXR2023-06-01
08800017284620LOSPA IS Spinal SystemCorentec Co., LtdHXR2022-10-20
00681490912235Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00681490912242Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00840319718230Hayden MedicalHayden Medical, Inc.HXR2022-08-03
00840319701492Hayden MedicalHayden Medical, Inc.HXR2022-07-22
00840319701508Hayden MedicalHayden Medical, Inc.HXR2022-07-22
04251436928604KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-09-22
04251436915178KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436921902KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436925115KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436925320KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436929359KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436929366KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436930638KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436930669KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
04251436932137KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGHXR2021-08-30
M36841601GrafcoGF HEALTH PRODUCTS, INC.HXR2021-06-03
00840314220134gSourceGSOURCE LLCHXR2020-11-02