AccessGUDID - DEVICE: Leg Sections (00887761970342)

GUDID

Device Identifier (DI) Information

Brand Name: Leg Sections
Version or Model: 1850979
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Baxter Medical Systems GmbH + Co. KG

Primary DI Number: 00887761970342
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330961223 *Terms of Use

Device Description: Leg section two parts spreadable H V

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42308	Operating table orthopaedic extension	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
GDC	TABLE, OPERATING-ROOM, ELECTRICAL
KXJ	Table, radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f1fb896-11d1-4267-86ed-ddbd90894340
Public Version Date: February 09, 2023
Public Version Number: 2
DI Record Publish Date: December 27, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4936715860
Email: SURGICAL@HILLROM.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES