FDA.report

Patient Support & Fixation

Primary DI
00887761971950
Brand
Patient Support & Fixation
Company
Baxter Medical Systems GmbH + Co. KG
Model
1582709
Device description
Belt for patients X-TRA
Published
2022-12-27
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
GDCTABLE, OPERATING-ROOM, ELECTRICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887761971950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761971950008877619719508877619719500887761971950

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00615521070069ALLENHILL-ROM, INC.GDC2026-02-27
00724995244972NASTERIS CORPORATIONGDC2026-02-13
06975678805018PAXShanghai PAX Medical Instrument Co., Ltd.GDC2026-02-13
04260647941494SC 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
04260647941500SC 5010 HSAKRUS GmbH & Co. KGGDC2025-11-28
04260647941579SB 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
04260647941586SB 5010 HSAKRUS GmbH & Co. KGGDC2025-11-28
04260647946321Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946338Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946345Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946376Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946383Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946390Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946406Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946420Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946437Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946444Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946451Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04946329173932Operating Table VACB-3006BMIZUHO CORPORATIONGDC2025-09-05
04946329308259Operating Table VACB-3006B Type150SMIZUHO CORPORATIONGDC2025-09-05
04946329385847Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329385854Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329385861Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329404555Operating Table MST-7300BXMIZUHO CORPORATIONGDC2025-09-05
07640143930043Intermediate plate Schaerer Medical AGGDC2025-07-23
07640143930050Intermediate plateSchaerer Medical AGGDC2025-07-23
07640143930166Side rail adapterSchaerer Medical AGGDC2025-07-23
07640143930180Side rail adapterSchaerer Medical AGGDC2025-07-23
07640143930807Side rail (1 pcs.)Schaerer Medical AGGDC2025-07-23
07640143930852Leg plates 2-part Schaerer Medical AGGDC2025-07-23