AccessGUDID - DEVICE: HARVEST NEEDLE (08033003342343)

GUDID

Device Identifier (DI) Information

Brand Name: HARVEST NEEDLE
Version or Model: HARVEST NEEDLE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES1110PD
Company Name: H.S. HOSPITAL SERVICE SPA

Primary DI Number: 08033003342343
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428898555 *Terms of Use

Device Description: HARVEST NEEDLE 11GX100MM

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?
47612	Bone marrow explant needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the sternum, hip bone, or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013070	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: 100 Millimeter
Needle Gauge: 11 Gauge

Device Record Status

Public Device Record Key: 41c23bc6-73a3-4a4f-9ede-e922396c54a9
Public Version Date: February 09, 2021
Public Version Number: 1
DI Record Publish Date: February 01, 2021