FDA.reportPublic FDA data

ArmGuard™

Primary DI
00811836030457
Brand
ArmGuard™
Company
D. A. Surgical
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040876183
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811836030129TrenGuard™553012021-05-17
00811836030105TrenGuard™552012021-05-17
00811836030143TrenGuard™554012021-05-17
00811836030174TrenGuard™561012021-05-17
00811836030198TrenGuard™562012021-05-17
00811836030211TrenGuard™563022021-05-17
00811836030235TrenGuard™564012021-05-17
00811836030396ArmGuard™401012021-05-17
00811836030419ArmGuard™404122021-05-17
00811836030082TrenGuard™551012021-05-17
00811836030433ArmGuard™402062021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851440007902Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CCX2026-07-22
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00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00842180148864ELMED INCORPORATEDELMED INCORPORATEDBWN2026-06-08
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
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
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
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