AccessGUDID - DEVICE: Bosma Enterprises (00818634020710)

GUDID

Device Identifier (DI) Information

Brand Name: Bosma Enterprises
Version or Model: 10-8020CIL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-8020CIL
Company Name: Bosma Enterprises

Primary DI Number: 00818634020710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878070325 *Terms of Use

Device Description: Accelerate-OR Lithotomy CIL Kit; Each Kit Includes 40x60 Sahara OR Table Sheet 20" Absorb (2), and 20x29 Disposable Pillowcase.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
47454	Basic pillowcase, single-use	A protective envelope for a pillow typically made of a thin-textile or reinforced-paper material intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	Active	false
62619	Surgical linen/cushion set	A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PWU	Clean-Up Kit

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
Special Storage Condition, Specify: Avoid excessive heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 30c86b01-6d0f-437e-8da9-4f58140882ca
Public Version Date: July 04, 2022
Public Version Number: 2
DI Record Publish Date: July 02, 2021