AccessGUDID - DEVICE: ALLEN (00615521017927)

GUDID

Device Identifier (DI) Information

Brand Name: ALLEN
Version or Model: 102001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I-LHSMNS
Company Name: HILL-ROM, INC.

Primary DI Number: 00615521017927
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004245668 *Terms of Use

Device Description: SIEMENS Leg Holder

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):	Yes
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?
11991	Heel stirrup	A device used during a medical/surgical procedure to steadily hold a patient's foot (feet) by cradling the heel. It is typically attached to an operating table, examination table, or treatment chair and is considered an accessory to these devices. This device is typically constructed of metal and plastic and used in pairs mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWZ	Operating Room Accessories Table Tray

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: 13a56770-6899-4f47-87b3-2f7d8ae7bfeb
Public Version Date: September 30, 2024
Public Version Number: 3
DI Record Publish Date: May 26, 2023

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)445-3730
Email: us.customerservice@hill-rom.com

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