AccessGUDID - DEVICE: Cell-HarvestOR (08057276004814)

GUDID

Device Identifier (DI) Information

Brand Name: Cell-HarvestOR
Version or Model: PSH1D21110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSH1D21110
Company Name: M.D.L. S.R.L.

Primary DI Number: 08057276004814
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 447228586 *Terms of Use

Device Description: MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm

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":	No
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
DWO	Needle, Biopsy, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 1fa741a1-8534-422e-8741-dd5e1218cc71
Public Version Date: May 07, 2025
Public Version Number: 1
DI Record Publish Date: April 29, 2025

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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