FDA.report

AlloWedge

Primary DI
00191083047331
Brand
AlloWedge
Company
Rti Surgical, Inc.
Model
55-C-22-16-8
Catalog number
55-C-22-16-8
Device description
COTTON TRIAL ASSEMBLY, 8mm
Published
2024-10-14
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

Related Records

Product Codes

CodeName
LHXTrousers, anti-shock

Product Code Classifications

CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191083047331PrimaryGS10

GMDN Terms

TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags

DUNS number
117560455
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00191083044446Meniscus Allograft Transplantation (MAT)9990009990002024-10-14
00191083044460Meniscus Allograft Transplantation (MAT)9990019990012024-10-14
00191083044477Meniscus Allograft Transplantation (MAT)9990029990022024-10-14
00191083044484Meniscus Allograft Transplantation (MAT)9990039990032024-10-14
00191083044491Meniscus Allograft Transplantation (MAT)9990049990042024-10-14
00191083044507Meniscus Allograft Transplantation (MAT)9990059990052024-10-14
00191083044514Meniscus Allograft Transplantation (MAT)9990069990062024-10-14
00191083044521Meniscus Allograft Transplantation (MAT)9990079990072024-10-14
00191083044538Meniscus Allograft Transplantation (MAT)9990089990082024-10-14
00191083044545Meniscus Allograft Transplantation (MAT)9990099990092024-10-14
00191083044552Meniscus Allograft Transplantation (MAT)9990109990102024-10-14
00191083044569Meniscus Allograft Transplantation (MAT)9990119990112024-10-14
00191083044576Meniscus Allograft Transplantation (MAT)9990129990122024-10-14
00191083044583Meniscus Allograft Transplantation (MAT)9990139990132024-10-14
00191083044606Meniscus Allograft Transplantation (MAT)9990169990162024-10-14
00191083046655Precision Allograft Cartilage Kit (PACK™)PAC-A0112PAC-A01122024-10-14
00191083046662Precision Allograft Cartilage Kit (PACK™)PAC-A0114PAC-A01142024-10-14
00191083046679Precision Allograft Cartilage Kit (PACK™)PAC-A0116PAC-A01162024-10-14
00191083046686Precision Allograft Cartilage Kit (PACK™)PAC-A0118PAC-A01182024-10-14
00191083046693Precision Allograft Cartilage Kit (PACK™)PAC-A0120PAC-A01202024-10-14

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