AccessGUDID - DEVICE: Compass Steerable Needle (00860009430228)

GUDID

Device Identifier (DI) Information

Brand Name: Compass Steerable Needle
Version or Model: CSN1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SERPEX MEDICAL INC.

Primary DI Number: 00860009430228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118905661 *Terms of Use

Device Description: Transbronchial Biopsy Needle

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):	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?
46678	Flexible endoscopic biopsy handpiece/needle	A sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTI	Bronchoscope Accessory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221206	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
Storage Environment Temperature: between -30 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 22 Gauge

Device Record Status

Public Device Record Key: f0041a36-6c25-461c-bd1e-3863321bab34
Public Version Date: March 27, 2023
Public Version Number: 1
DI Record Publish Date: March 17, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18009838698
Email: info@serpexmedical.com

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