AccessGUDID - DEVICE: Tulip GEMS™ Single-Use (00819127024093)

GUDID

Device Identifier (DI) Information

Brand Name: Tulip GEMS™ Single-Use
Version or Model: DPK-GOLD+INJ-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tulip Medical Products

Primary DI Number: 00819127024093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113564152 *Terms of Use

Device Description: Tulip Single Use, One Patient Gold Kit Plus Injectors

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
63046	Autologous adipose tissue collection/injection set	A collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

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
No Device Sizes

Device Record Status

Public Device Record Key: 1c24b997-538e-477d-a136-640196dfee0e
Public Version Date: November 14, 2024
Public Version Number: 1
DI Record Publish Date: November 06, 2024