FDA.report

AQUALGEL

Primary DI
00724995219956
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LWGSURGICAL TABLE CUSHION

Product Code Classifications

CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10724995219953PrimaryGS10
00724995219956Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499521995310724995219953
00724995219956007249952199567249952199560724995219956

GMDN Terms

TermDefinition
Heel stirrup cushion/padA 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

TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
036985604
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00724995153762AmscoWarming CabinetDJ0501443322026-02-13
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00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13
00724995222086NATable ExtensionBF002662026-02-13
00724995222093NATable ExtensionBF002672026-02-13
00724995222109NATable ExtensionBF002682026-02-13
00724995244972NATAB800KTLBF7942026-02-13
00724995246891NATable Pad S00XWBF7682026-02-13
00724995246907NATable Pad S20CV3BF7692026-02-13

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