AccessGUDID - DEVICE: Sterimed (00867878000415)

GUDID

Device Identifier (DI) Information

Brand Name: Sterimed
Version or Model: 0284-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STERIMED LLC

Primary DI Number: 00867878000415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080284658 *Terms of Use

Device Description: Band Bag 7" X 9" - 2 products/package (0284-2)

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":	Yes
For Single-Use:	Yes
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?
43071	X-ray system cover	A sterile piece of material used to cover an x-ray system during a surgical procedure to create a sterile barrier between the sterile operating field and the x-ray system, or the prominent parts of the x-ray system that intrude the sterile field. Since x-ray systems cannot be sterilized, this device is draped over/attached to the x-ray system allowing its use without compromising the sterile field. It will also protect the x-ray system from patient contaminants. It is available in a variety of shapes and sizes. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IZI	System, X-Ray, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K853044	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: eb15483a-a8b6-4d7a-9daf-502398c2ecd3
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: September 18, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20867878000419	4	10867878000412		In Commercial Distribution	Case
10867878000412	100	00867878000415		In Commercial Distribution	Inner Pack/Box

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 770-387-0771
Email: xx@xx.xx

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