FDA.report

ALLEN

Primary DI
00615521014155
Brand
ALLEN
Company
ALLEN MEDICAL SYSTEMS, INC.
Model
102005
Catalog number
F-CLK
Device description
CYSTO, KC, NO CLAMP
Published
2023-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615521014155PrimaryGS10

GMDN Terms

TermDefinition
Leg procedure positionerA preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags

DUNS number
147805894
Device count
1
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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00615521004408ArthrexAR-1627-11EU2024-05-23
00615521004415ArthrexAR-1627-11UK2024-05-23
00615521004422ArthrexAR-1627-122024-05-23
00615521004439ArthrexAR-1627-12EU2024-05-23
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00615521004491ArthrexAR-1627-172024-05-23
00615521004507ArthrexAR-1627-182024-05-23
00615521004514ArthrexAR-1627-202024-05-23
00615521004521ArthrexAR-1650-012024-05-23
00615521004552ArthrexAR-1650-042024-05-23
00615521004569ArthrexAR-1650-052024-05-23
00615521004583ArthrexAR-1650-072024-05-23
00615521004590ArthrexAR-1650-082024-05-23
00615521004606ArthrexAR-1650-092024-05-23
00615521004613ArthrexAR-1650-102024-05-23
00615521004620ArthrexAR-1650-112024-05-23
00615521004668ArthrexAR-1713-012024-05-23

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