AccessGUDID - DEVICE: Salman FES Stent (EBESSS20000)

GUDID

Device Identifier (DI) Information

Brand Name: Salman FES Stent
Version or Model: SS2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS2000
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESSS20000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Over the Counter (OTC):	No
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?
48121	Paranasal sinus spacer	A sterile device temporarily introduced into the sinus to maintain an opening and prevent obstruction. It is used for the local moistening of the sinuses through delivery of a selected fluid (e.g., saline or a drug) to treat sinusitis. It is typically designed as a microflow catheter with a micropore reservoir at the distal end which gradually releases the fluid. The implantation procedure is assisted through fluoroscopy or endoscopy. A disposable sinus spacer deployment device will typically be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KAM	Cannula, Sinus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922902	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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14d53864-efa7-48c0-a0e6-1a696dff8cfa
Public Version Date: August 30, 2022
Public Version Number: 5
DI Record Publish Date: September 20, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
EBESSS20001	1	EBESSS20000		In Commercial Distribution	Carton

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

Customer Contact

[?]

Phone: 1-800-433-2674
Email: info@bosmed.com

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