FDA.report

TAP-LIF Instruments

Primary DI
03613720216100
Brand
TAP-LIF Instruments
Company
MEDICREA INTERNATIONAL
Model
A15000417
Device description
CURVED RONGEUR 4mm
Published
2017-02-01
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

Related Records

Product Codes

CodeName
HTXRongeur

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03613720216100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03613720216100036137202161003613720216100

GMDN Terms

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
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 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 DIBrandCompanyProduct codePublished
00810055250189Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810055250202Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450509Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450516Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450547Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450554Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450561Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450578Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450585Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450592Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450608Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450615Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450622Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450639Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450646Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450653Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450660Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451322Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451339Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451346Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451353Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451360Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451377Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451384Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451391Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451407Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451414Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451520Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451544Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451551Surgical DesignSurgical Design, Inc.HTX2026-05-23