AccessGUDID - DEVICE: Birkova (00724995212001)

GUDID

Device Identifier (DI) Information

Brand Name: Birkova
Version or Model: Arm Hand Table Pads
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HT52012PM
Company Name: STERIS CORPORATION

Primary DI Number: 00724995212001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: T-Wing Shape Arm Hand Table Pad, 2 PM Series

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?
41141	Arm cushion	A soft pillow or pad used to provide support and comfort to the user's arm, typically during the treatment and/or prevention of musculoskeletal or circulatory disorders (e.g., muscle sprain/strain, lymphoedema). The device may be used to support various areas of the arm (i.e., wrist, elbow, or shoulder).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	SURGICAL TABLE CUSHION

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: a0e59f57-77a2-4fb5-9188-3d3781ffa682
Public Version Date: July 08, 2021
Public Version Number: 1
DI Record Publish Date: June 30, 2021

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

Customer Contact

[?]

Phone: +1(800)548-4873
Email: xx@xx.xx

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

FDA TOOLS & RESOURCES