FDA.reportPublic FDA data

Pelvis Sections

Primary DI
00887761970229
Brand
Pelvis Sections
Company
Baxter Medical Systems GmbH + Co. KG
Model
1951369
Device description
Pelvic extension H V J
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
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
00887761970229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761970229008877619702298877619702290887761970229

GMDN Terms

TermDefinition
Operating table orthopaedic extensionAn orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates.

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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00842430101328SPAR, LEG, LEFT, RADIOLUCENT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101335SPAR ASSEMBLY, RIGHT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430101342SPAR ASSEMBLY, LEFT, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
00842430103414UPPER ARM SUPPORT & PAD, REFURBISHEDMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2023-09-19
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