FDA.reportPublic FDA data

WaffleGrip PadLock Bracket Set

Primary DI
00850011479643
Brand
WaffleGrip PadLock Bracket Set
Company
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Model
A330
Catalog number
A330
Device description
WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pad
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850011479643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011479643008500114796438500114796430850011479643

GMDN Terms#

Term, Definition table
TermDefinition
Operating table non-slip back padA non-slip cushioned pad, typically with a pressure-sensitive adhesive, intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table and prevent them from sliding on the table top, typically while placing them in the Trendelenburg position or applying traction pulling forces on the legs during surgery; it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. Additional securing devices [e.g., straps, adaptors, clamps] may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 952 465 3500cs@augsurg.com

Regulatory Flags#

DUNS number
965879187
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011479810Hillrom powered by Augustine Surgical HD208915320891532026-04-23
00855913001848"HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35"")"U530U5302024-09-12
00855913001817"HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32"")"U501U5012023-07-17
00855913001824"HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"")"U502U5022023-07-17
00855913001978Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming AccessoryA300A3002016-09-28
00855913001992HotDog Universal Warming BlanketB500B5002022-10-10
00850011479018HotDog Temperature Management SystemWC71WC712022-05-17
00850011479025HotDog Temperature Management SystemWC77WC772022-05-17
00850011479582Hillrom powered by Augustine Surgical HD208351620835162022-05-17
00850011479599Hillrom powered by Augustine Surgical HD208351820835182022-05-17
00850011479605Hillrom powered by Augustine Surgical HD208351920835192022-05-17
00850011479612Hillrom powered by Augustine Surgical HD208352020835202022-05-17
00850011479629Hillrom powered by Augustine Surgical HD208352120835212022-05-17
00855913001015Hot Dog Patient Warming System ControllerWC02WC022016-09-28
00855913001091Hot Dog Lower Body Warming Blanket, PediatricB203B2032016-09-28
00855913001107Hot Dog Patient Warming System Controller WC01WC01WC012016-09-28
00855913001251Hot Dog Lower Body Warming BlanketB103B1032016-09-28
00855913001268Hot Dog Full Body Warming BlanketB104B1042016-09-28
00855913001381Hot Dog Multi-Position Warming BlanketB105B1052016-09-28
00855913001398Hot Dog Head Warming BlanketB107B1072016-09-28

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Primary DI, Brand, Company table
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00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
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