FDA.reportPublic FDA data

ArmGuard™

Primary DI
10811836030454
Brand
ArmGuard™
Company
Dan Allen Surgical LLC
Model
40207
Device description
ArmGuard XL Width Extender Packs - Each Pack contains: Two Width Extender Pads for table mattresses up to 4 in 10.2 cm.Case of 12 ea. 00811836030457 (model #40204)
Published
2021-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811836030454PrimaryGS10
00811836030457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081183603045410811836030454
00811836030457008118360304578118360304570811836030457

GMDN Terms#

Term, Definition table
TermDefinition
Operating table mattress extension padA cushioned pad intended to increase the surface area of an operating table mattress upon which the patient is placed. It is attached to the operating table (e.g., table rails, patient restraint anchor) and is typically used to extend the mattress width to support a bariatric patient’s arms during a surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
040876183
Device count
12
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
00811836030006TrenGuard™56100561002021-05-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22