FDA.report

Patient Support & Fixation

Primary DI
00887761971981
Brand
Patient Support & Fixation
Company
Baxter Medical Systems GmbH + Co. KG
Model
1436366
Device description
Cushion for sternum support small
Published
2023-01-03
Public version status
Update
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
JEATABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887761971981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761971981008877619719818877619719810887761971981

GMDN Terms

TermDefinition
Patient positioning vacuum padA device designed to position and immobilize parts of the patient (e.g., head, extremities) typically during therapeutic interventions or patient transportation. The device immobilizes a body part by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the part that it encompasses until the vacuum is released.

Sterilization Methods

Method

Contacts

PhoneEmail
+4936715860SURGICAL@HILLROM.COM

Regulatory Flags

DUNS number
330961223
Device count
1
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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00887761943209Pads20853752025-01-20
00887761975682Control Units20822962025-01-20
00887761975699Control Units20822952025-01-20
00887761968554Sterilizable Handles40257082023-07-11
00887761968547Sterilizable Handles40257092023-07-11
00887761968561Sterilizable Handles16602142023-06-26
008877619764364K Refreshing Unit41080622023-03-07
008877619764434K Camera41080612023-03-07
00887761976450Pre-Install Set Helux Pro41080512023-03-07
00887761976474Helux Pro Surgical Light41081202023-03-07
00887761977334Helux Pro Surgical Light41084102023-03-07
00887761977341Helux Pro Surgical Light41083102023-03-07
00887761977358Helux Pro Surgical Light41082102023-03-07
00887761977365Helux Pro Surgical Light41081402023-03-07
00887761977389Helux Pro Surgical Light41081102023-03-07
00887761967342Orthopedic Extension12188362023-01-17
00887761967380Pads20772862022-12-14
00887761967397Pads20772872022-12-14
00887761967403Leg Sections20775882022-12-14
00887761967410Carbon Sections20775842022-12-14

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00840343723156FusionMAXSURGIX MEDICAL LLCJEA2024-08-19
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04250435539521DORO® LUCENT iMRI Interface Adaptor IMRISpro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer AusrüstungJEA2023-10-25
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00842430101328SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
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00842430105500Trios/OTS Lateral Extension PadMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430106590Radiolucent Leg Spar RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430106613Hana Radiolucent Leg Spar LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107498Zentrum ZXT System, EUMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107504Zentrum ZXT System, JPMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430107511Zentrum ZXT System, USMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430108532TRACTION BOOT & PLATE, SMALL, LT & RTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430108549TRACTION BOOT & PLATE, LARGE, LT & RTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19