AccessGUDID - DEVICE: Sterimed (00850341007103)

GUDID

Device Identifier (DI) Information

Brand Name: Sterimed
Version or Model: 0586L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STERIMED LLC

Primary DI Number: 00850341007103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080284658 *Terms of Use

Device Description: Extra Long C-Arm Cover 36" X 103"

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?
45640	C-arm drape	A sterile device intended to cover/wrap the C-arm and/or mini C-arm of a mobile or stationary fluoroscopic x-ray system and function as a physical barrier to prevent cross-contamination between the C-arm and the surgical staff/field during a procedure. It is typically made of flexible plastic and shaped to fit the C-arm; it is available in various 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: e1ed7967-c934-4963-8036-09806f6e72fb
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: September 19, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20850341007107	4	10850341007100		In Commercial Distribution	Case
10850341007100	20	00850341007103		In Commercial Distribution	Iner 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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