AccessGUDID - DEVICE: Smart Syringe (08800080211011)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Syringe
Version or Model: SKT-SS-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BSL Co.,Ltd

Primary DI Number: 08800080211011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694860273 *Terms of Use

Device Description: No description.

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):	Yes
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 reinjection set	A collection of devices which includes an invasive cannula/needle, intended for both harvesting fat tissue from a patient (liposuction) and subsequently injecting the fat tissue into the patient from whom it was taken (autologous lipotransfer) as part of a surgical procedure (e.g., reconstructive/cosmetic, orthopaedic, spinal); it may additionally be intended to process the adipose tissue. In addition to needles/cannulae, it includes syringes, accessories (e.g., caps, connectors), and may include collection/processing devices (e.g., filtration bag). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK220722	0

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: 52a0b324-77ec-4142-b425-deeb2d983627
Public Version Date: July 21, 2025
Public Version Number: 3
DI Record Publish Date: May 11, 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
08800080211028	12	08800080211011		In Commercial Distribution
08800080211035	48	08800080211011		In Commercial Distribution

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: +82553289235
Email: bsl@biosl.com

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