DEVICE: Bosma Enterprises (00818634020772)
Device Identifier (DI) Information
Bosma Enterprises
10-8020ORL
In Commercial Distribution
10-8020ORL
Bosma Enterprises
10-8020ORL
In Commercial Distribution
10-8020ORL
Bosma Enterprises
Accelerate-OR Cysto ORL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 24x24 Red Liner 1.2 mil 10 gal Bag, Non-sterile Drain Bag Pouch, 4x60 Foam Positioning Strap, and MicroMax Microfiber Mop Head 18" w/ Scrubber Strips.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
65175 | Operating room turnover kit |
A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.
|
Active | false |
12223 | Bucket liner |
A device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device.
|
Active | false |
44851 | Limb/torso/head restraint, single-use |
A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. 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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Avoid excessive heat. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f1381bcd-b035-4a2f-be94-d5f4e90c375f
July 12, 2021
1
July 02, 2021
July 12, 2021
1
July 02, 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 |
---|---|---|---|---|---|
10818634020779 | 12 | 00818634020772 | In Commercial Distribution | Case |
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-362-5463
kimm@bosma.org
kimm@bosma.org