FDA.reportPublic FDA data

AQUALGEL

Primary DI
10724995219953
Brand
AQUALGEL
Company
STERIS CORPORATION
Model
BF477
Catalog number
BF477
Device description
AQUAGEL Heel Protector are 3-dimensional and provide heel protection and positioning stability.
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWGSURGICAL TABLE CUSHION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995219953PrimaryGS10
00724995219956Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499521995310724995219953
00724995219956007249952199567249952199560724995219956

GMDN Terms#

Term, Definition table
TermDefinition
Heel stirrup cushion/pad, reusableA pad designed to be placed between a patient's foot and a table heel stirrup, cushioning the patient's heel and lower leg to provide greater comfort and to reduce the risk of sores during long procedures. The device is typically made of soft material (e.g., foam) with an appropriate shape and size to fit the heel stirrup; it is usually supplied in pairs. The device is used mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
2
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10885403015960V. MuellerBP0-1ABP01A2017-11-17
10885403015977V. MuellerBP0-2ABP02A2017-11-17
10885403015991V. MuellerBP0-2VBP02V2017-11-17
10885403016004V. MuellerBP1-1ASBP11AS2017-11-17
10885403016011V. MuellerBP1-2ABP12A2017-11-17
10885403016035V. MuellerBP1-2ASBP12AS2017-11-17
10885403016066V. MuellerBP1-2VBP12V2017-11-17
10885403016073V. MuellerBP1-2VSBP12VS2017-11-17
10885403016080V. MuellerBP1-3ABP13A2017-11-17
10885403016103V. MuellerBP1-3VBP13V2017-11-17

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Primary DI, Brand, Company table
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