FDA.reportPublic FDA data

TrenGuard™

Primary DI
00811836030006
Brand
TrenGuard™
Company
Dan Allen Surgical LLC
Model
56100
Catalog number
56100
Device description
TrenGuard Patient Support Frame - For use with TrenGuard Packs and accessories.
Published
2021-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811836030006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811836030006008118360300068118360300060811836030006

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioner base plateA device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040876183
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811836030273ShroudGuard™373502025-07-09
00811836030266ShroudGuard™OZ 8800200382025-03-11
00811836030891TrenGuard™569492024-11-11
00811836030204TrenGuard™56400564002022-08-18
00811836030815TrenGuard™569292021-05-17
00811836030075ShroudGuard™373032024-11-11
00811836030440TrenGuard™546122024-11-11
00811836030600ShroudGuard™371102024-11-11
00811836030846TrenGuard™548122024-11-11
00811836030259ShroudGuard™373242024-10-24
00811836030754ShroudGuard™373142024-06-25
00811836030761ShroudGuard™373122024-06-25
00811836030778ShroudGuard™373102024-06-25
00811836030860TrenGuard™569102023-01-31
10811836030089TrenGuard™553012021-05-17
10811836030102TrenGuard™552012021-05-17
10811836030140TrenGuard™554012021-05-17
10811836030171TrenGuard™561012021-05-17
10811836030195TrenGuard™562012021-05-17
10811836030218TrenGuard™563022021-05-17

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