AccessGUDID - DEVICE: TRAPSYSTEM SET (08033003349632)

GUDID

Device Identifier (DI) Information

Brand Name: TRAPSYSTEM SET
Version or Model: TRAPSYSTEM SET
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRAPJ 0815
Company Name: H.S. HOSPITAL SERVICE SPA

Primary DI Number: 08033003349632
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428898555 *Terms of Use

Device Description: TRAPSYSTEM 8GX150MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
46350	Bone marrow biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013692	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
Length: 150 Millimeter
Needle Gauge: 8 Gauge

Device Record Status

Public Device Record Key: 58289177-bff3-4800-a48c-6b91599136f2
Public Version Date: December 27, 2019
Public Version Number: 1
DI Record Publish Date: December 19, 2019